PaxMed achieves the 221st 510(k) clearance

The list below will give you an idea of the scope of our 510(k) work.

K Number
Date
Company
Product Name
Product Code
510K Review Panel
FDA Link
K1918482019-09-30Medartis, AGAPTUS® Wrist Spanning Plates 2.5HRS, HWCOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K191848
K1916362019-08-16Medartis, AGAPTUS® Foot SystemJDROrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K191636
K1904912019-08-12Blue Sky BioBlue Sky Bio Zygomatic Implant SystemNHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K190491
K1912222019-08-05Prismatik Dentalcraft, Inc.Inclusive® Titanium AbutmentsNHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K191222
K1822462019-04-16Imagine Milling TechnologiesMIST ICNHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K182246
K1809242019-03-29Integrated Dental SystemsReflect™ Implant SystemDZE, NHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K180924
K1835182019-03-18Preat CorporationEndosseous Dental Implant AbutmentNHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K183518
K1802042018-12-28Visionare, LLCCranioMaxillofacial Fixation (CMF) System - CMF VisionareJEY, DZLOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K180204
K1818502018-11-14Southern Implants (Pty) Ltd.Inversa ImplantsDZEDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K181850
K1817212018-09-17Curasan AGCeracell Ortho FoamMQVOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K181721
K1804652018-09-06Southern Implants (Pty) Ltd.Provata Implant SystemDZE, NHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K180465
K1805362018-08-30NeodentGM Line AdditionsDZEDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K180536
K1810092018-08-24Medartis, AGAPTUS® CMC-I Fusion SystemHRSOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K181009
K1814252018-08-05Medartis, AGAPTUS® Proximal Humerus SystemHRS, HTY, HWCOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K181425
K1739082018-06-15Terrats Medical SLDESS Dental Smart SolutionsNHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K173908
K1739022018-04-20NeodentNeodent Implant System - GM LineNHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K173902
K1735252018-04-06OsteoNovus, Inc.NovoGroMQVOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K173525
K1717132018-04-05NeodentNeodent Instrument KitsKCTDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K171713
K1733432018-02-27Southern Implants (Pty) Ltd.Zygomatic Implant SystemDZEDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K173343
K1716222018-01-11Dentium Co., LtdDentium Ti-BaseNHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K171622
K1725732017-12-15Orthorebirth Co., LtdReBOSSIS85MQVOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K172573
K1733742017-12-13Biomet 3iTSV BellaTek Encode Healing AbutmentsNHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K173374
K1703922017-12-01S.I.N. - Sistema De Implante Nacional S.A.S.I.N. Dental Implant SystemDZEDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K170392
K1703982017-11-21S.I.N. - Sistema De Implante Nacional S.A.S.I.N. Dental Implant SystemDZE, NHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K170398
K1636342017-11-06Southern Implants (Pty) Ltd.External Hex ImplantsDZE, NHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K163634
K1717952017-09-29Thommen Medical, AGThommen Implant SystemDZE, NHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K171795
K1721702017-09-08Medartis, AGAPTUS® Wrist 2.5 SystemHRSOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K172170
K1705882017-08-08Terrats Medical SLDESS Dental Smart SolutionsNHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K170588
K1706202017-06-23Orthorebirth Co., LtdREBOSSIS85MQVOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K170620
K1620872017-04-18OsteoNovus, Inc.NovoGroMQVOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K162087
K1618612017-02-09Medartis, AGAPTUS® Coronoid 2.0HRSOrthopedichttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K161861
K1626772016-12-21Rhondium, Ltd.L-OVCEIHDentalhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K162677
K1617132016-12-16Dentium Co., LtdDentium CAD/CAM AbutmentsNHADentalhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K161713
K1607862016-11-21Rodo Medical, Inc.Rodo Abutment SystemNHADentalhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K160786
K1609792016-11-04Prismatik Dentalcraft, Inc.Inclusive® AbutmentsNHADentalhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K160979
K1607842016-09-14CamlogCAM Titanium BlanksNHADentalhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K160784
K1532742016-08-04Snyder Industries, Inc.Med-Tainer Single Deposit Container (SDC)MMKGeneral Hospitalhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K153274
K1602442016-06-02Thommen Medical, AGVARIOuniteNHADentalhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K160244
K1530642016-04-29Blue Sky BioBlue Sky Bio Zygomatic Implant SystemDZE, NHADentalhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K153064
K1537792016-03-31CamlogAbutment for BridgesNHADentalhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K153779
K1519842016-03-10Thommen Medical, AGMilling Abutment for CAD/CAMNHADentalhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K151984
K1517892016-03-04Zest Anchors, LLCLOCATOR F-Tx Attachment SystemNHADentalhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K151789
K1525682016-02-11Cardinal SpineC-VBRPLROrthopedichttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K152568
K1525092016-01-12CamlogCAMLOG® and CONELOG® Abutments For Screw-retained Restorations (ASR)NHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K152509
K1519162015-12-18Tri Dental Implants Int. AGTRI® Dental Implant SystemDZE, NHADentalhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K151916
K1502032015-10-23Medentika GmbHCAD/CAM AbutmentsNHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K150203
K1515992015-10-02CamlogiSy® Implant SystemDZE, NHADentalhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K151599
K1500212015-07-31Z-SystemsZ5m(t)DZEDentalhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K150021
K1502952015-07-24Zest Anchors, LLCLOCATOR RTxNHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K150295
K1417772015-07-20NeodentNeodent Implant SystemDZE, NHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K141777
K1503672015-07-13NeodentNeodent Implant SystemNHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K150367
K1501992015-06-15NeodentNeodent Implant SystemDZE, NHADentalhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K150199
K1429062015-06-09Medartis, AGAPTUS® Wrist 2.5 SystemHRS, HWCOrthopedichttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K142906
K1436942015-05-15Rhondium, Ltd.One-Visit-CrownEBFDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K143694
K1425812015-04-09Medartis, AGAPTUS® Foot SystemHRS, HWCOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K142581
K1421672015-02-20Medentika GmbHMedentika Abutment SystemNHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K142167
K1433372015-02-17CamlogCONELOG® Titanium Base CAD/CAMNHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K143337
K1420302015-01-23Cardinal SpineSTGC-LordoticMQPOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K142030
K1424192014-12-16Neoortho Produtos Ortopedicos S/AMini and Micro Fragments Reconstruction NEOFIXHRS, HWCOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K142419
K1338272014-11-17OsteoVasiveA-Link Z IVB Fusion DeviceOVDOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K133827
K1420902014-10-29Orthorebirth Co., LtdReBOSSISMQVOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K142090
K1411032014-09-23NeoorthoItramedullary Nails and Screws NEONAILHSBOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K141103
K1339912014-08-06CamlogiSy SystemDZE, NHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K133991
K1328812014-07-03Z-SystemsZ5cDZE, NHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K132881
K1333272014-06-25Zest Anchors, LLCSaturno Overdenture Implant SystemDZEDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K133327
K1412322014-06-23Medartis, AGAPTUS® Ulna Shortening 2.5HRS, HWCOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K141232
K1405702014-06-16Zest Anchors, LLCChairside Attachment Processing MaterialEBIDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K140570
K1330182014-02-26Orthopedic Sciences, IncOSI Q System ArthoscopesHRXOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K133018
K1336962014-02-25NeodentNeodent Implant SystemNHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K133696
K1335102014-02-24NeodentNeodent Implant SystemDZE, NHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K133510
K1327922014-01-31Daniels SharpsmartEcoship Disposable SharpsMMKGeneral Hospitalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K132792
K1334602013-12-18Medartis, AGAPTUS® Cannulated Screws 5, 7HWC, HTYOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K133460
K1211772013-12-05Augma BiomaterialsBond ApatiteLYCOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K121177
K1309992013-10-25Dentsply ImplantOsseoSpeed Profile EvDZE, NHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K130999
K1317012013-09-05Z-SystemsZ5 Mlb MlcDZEDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K131701
K1313452013-08-07NasseoTiArray Dental Implant SystemDZE, NHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K131345
K1307872013-06-13Quantum Bioengineering, Ltd.Quantum™ Dental Implant SystemDZEDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K130787
K1230222013-05-17NeodentNeodent Implant SystemDZE, NHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K123022
K1302162013-05-01Dentsply ImplantAtlantis Abutment for Straumann BLNHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K130216
K1221982013-04-05Oco BiomedicalI Macro 6.0mm X 6.0mm ImplantDZEDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K122198
K1237512013-02-28Wellspect HealthcareLoFric® SenseEZDUrologyhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K123751
K1200382013-02-14RenovisA200 Knee SystemJWHOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K120038
K1218102013-01-23Astra TechOsseoSpeed Angled EvNHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K121810
K1207932012-12-21Z-SystemsZ-Look3 Evo SLMDZEDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K120793
K1137792012-12-14CamlogCONELOGDZE, NHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K113779
K1211172012-12-14National DentexNDX Custom AbutmentsNHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K121117
K1220782012-10-31Astra TechLoFric® PrimoTM and LoFric® Hydro-KitTMEZDUrologyhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K122078
K1211762012-08-17Cardinal SpineSTGCMQPOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K121176
K1213342012-08-14Thommen Medical, AGVARIOecoNHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K121334
K1204142012-07-31Astra TechOsseoSpeed PlusDZEDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K120414
K1201762012-07-25CentrixSenzzzzz AwayLBHDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K120176
K1122792012-05-04Quantum Bioengineering, Ltd.Quantum™ Dental Implant SystemDZE, NHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K112279
K1201082012-04-27Medartis, AGAPTUS® Proximal HumerusHRSOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K120108
K1134242012-04-17Astra TechLoFric® Pobe CatheterEZODentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K113424
K1137332012-03-23NeoorthoSmall and Large Fragments Osteosynthesis System NEOFIXHRS, HWCOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K113733
K1104042012-02-16CorentecEAUMTotal Knee SystemJWHOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K110404
K1120462012-01-06AngelusMTA AngelusKIFDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K112046
K1135682012-01-06AngelusMTA FillapexKIFDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K113568
K1121692012-01-06Medartis, AGAPTUS® Wrist Arthrodesis PlatesHRSOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K112169
K1125602011-12-15Medartis, AGAPTUS® Distal Humerus SystemHRS, HWCOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K112560
K1128572011-12-13BiostructuresInterface Bone Void FillerMQVOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K112857
K1119442011-11-22Pioneer Surgical TechnologyNB3D Bone Void FillerMQVOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K111944
K1119842011-11-10Thommen Medical, AGSPI VARIO Angled AbutmentNHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K111984
K1104422011-11-09NanovisNanovis Intervertebral Body Fusion SystemODP, MAXOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K110442
K1112872011-09-26Astra TechAstra Tech Implant SystemDZE, NHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K111287
K1034312011-07-21CorentecCOREN Total Hip SystemLPHOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K103431
K1109082011-06-28Medartis, AGAPTUS® Foot 3.5 SystemHRS, HWCOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K110908
K1010052011-06-21Astra TechAstra Tech Implant System, New ComponentNHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K101005
K1106582011-06-02Medartis, AGAPTUS® Cannulated Compression ScrewsHWCOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K110658
K1109652011-05-11RenovisRenovis T 710 Large External Fixation SystemKTTOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K110965
K1105612011-04-29Pioneer Surgical TechnologyFortrOss Bone Void FillerMQVOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K110561
K1028042011-04-20Thommen Medical, AGSPI Titanium Base For Cad/CamNHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K102804
K1006982011-03-14Cardinal SpineSTCCODPOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K100698
K1017322011-02-23Astra TechAstra Tech Implant SystemDZEDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K101732
K1027692011-02-23NeodentNeodent Implant SystemOATDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K102769
K1030842011-02-14NeodentNeodent Implant SystemDZLDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K103084
K1019452011-01-26NeodentNeodent Implant SystemDZE, NHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K101945
K1033322011-01-24Medartis, AGAPTUS® Ulna PlatesHRS, HWCOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K103332
K1032522011-01-10CamlogCAMLOG Vario SR AbutmentsNHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K103252
K1026412010-12-20NeoorthoMini and Micro Fragments Reconstruction System-NeofaceJEYDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K102641
K1025372010-12-10Medartis, AGAPTUS® 1.5 TrilockHRSOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K102537
K0925412010-11-09BiostructuresInterface (Extremity, Alone)MQVOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K092541
K1014262010-09-15Mathys LtdCeros TCP GranulesLYCDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K101426
K1017982010-08-19Thommen Medical, AGSPI VARIOmulti Angled AbutmentNHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K101798
K1012072010-08-02NeodentNeodent Implant SystemDZEDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K101207
K1003612010-04-22Pioneer Surgical TechnologyNanoss Bone Void Filler (Fortross Syringe)MQVOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K100361
K0936152010-03-04Thommen Medical, AGSPI Dental Implant, ElementDZEDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K093615
K0910312009-11-17Pioneer Surgical TechnologyPioneer Surgical Nanoss BVF-EMQVOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K091031
K0920822009-10-02Synergy Surgical TechnologiesSynergy Cannulated Screw SystemHTNOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K092082
K0922482009-09-25Thommen Medical, AGSPI Customizable Gingiva FormerNHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K092248
K0920382009-09-23Medartis, AGAPTUS® K-Wire SystemHTYOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K092038
K0912392009-09-22Astra TechAstra Tech Implant SystemDZEDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K091239
K0901542009-07-27Thommen Medical, AGSPI Dental Implant InicellDZEDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K090154
K0914792009-07-13Medartis, AGAPTUS® Foot SystemHRS, HWCOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K091479
K0909832009-07-01Medartis, AGAPTUS® 2.0/2.3 Four Corner Fusion PlateHRSOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K090983
K0903472009-06-18CamlogCAMLOG Abutments PSNHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K090347
K0900532009-04-23Medartis, AGAPTUS® 2.0 Radial Head SystemHRS, HWCOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K090053
K0901532009-03-27Thommen Medical, AGSPI VARIOmulti Angled AbutmentNHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K090153
K0838582009-03-17Augma BiomaterialsBond BoneLYCOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K083858
K0835432009-03-06DenovisDenovisMed Dental Implant SystemsDZE, NHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K083543
K0834962009-01-30CamlogCAMLOG Implant System Modified Implants And AbutmentsDZE, NHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K083496
K0821802008-12-17AngelusPerma Fiber /Perma MeshEBIDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K082180
K0814602008-11-21Pou Yu Biotechnology Co, LtdTDS AbutmentNHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K081460
K0820582008-10-02CookDynaMatrixNPLDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K082058
K0801562008-09-17Astra TechOsseoSpeed Profile SystemDZE, NHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K080156
K0736852008-08-29Osseous Technology of AmericaOTA Collagen BiomaterialNPLOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K073685
K0817902008-07-24Trinity Orthopedics, LLCModification to SPMA Pedicle Screw SystemMNI, MNHOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K081790
K0811572008-07-22CagenixAccuframeNHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K081157
K0710742008-07-02Showa Ika Kohgyo Co.,Ltd.MYKRES Spinal SystemKWP, KWQ, MNHOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K071074
K0803962008-04-30Astra TechOsseoSpeed NarrowDZE, NHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K080396
K0735532008-03-05CamlogCAMLOG Implant System AbutmentsNHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K073553
K0728562008-02-15Thommen Medical, AGSPI VARIOmulti AbutmentNHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K072856
K0726492007-12-06Thommen Medical, AGSPI System Dental ImplantsDZEDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K072649
K0731412007-12-05Thommen Medical, AGSPI Art AbutmentNHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K073141
K0730542007-11-27Cayenne Medical, Inc.Modification To AperFix Femoral Implant With InserterHWCOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K073054
K0729332007-11-15Thommen Medical, AGSPI Contact Platform O 4.0 MmDZE, NHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K072933
K0625422007-10-29Z-SystemsZ-Look3 Dental Implant System, Model Z3-XXXDZEDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K062542
K0710702007-10-23KeystoneOlympus Dental Implant SystemDZE, NHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K071070
K0717962007-10-19Cayenne Medical, Inc.Capsew Plication SystemGATOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K071796
K0716382007-10-10BioHorizonsBioHorizons Tapered Internal Implant SystemDZE, NHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K071638
K0726242007-10-01Astra TechAstra Tech Implant System, New ComponentNHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K072624
K0714532007-09-19Thommen Medical, AGSPI EASY 4.0 AbutmentNHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K071453
K0716122007-09-11Medartis, AGMODUS Trilock 2.0/2.3/2.5JEYDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K071612
K0712132007-08-10CamlogCAMLOG Logfit Prosthetic SystemNHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K071213
K0715002007-08-10PentronNano-Bond II Adhesive SystemKLEDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K071500
K0717432007-07-064th ColumnPillar Pedicle Screw SystemMNI, MNHOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K071743
K0702952007-05-21Trinity Orthopedics, LLCSingle Planar Multi Axial (SPMA) Pedicle Screw SystemMNI, MNHOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K070295
K0637792007-04-27Astra TechOsseoSpeed 4.0s-6mm, Model 24619DZEDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K063779
K0702902007-04-17Thommen Medical, AGSPI VECTODRILL Ceramic DrillsNDPDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K070290
K0632052007-02-26Atlas Spine LLCAtlas Spine Vertebral Body ReplacementMQPOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K063205
K0637942007-01-24LDR Spine USAModification to Easyspine SystemMNI, MNHOpthalmichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K063794
K0700072007-01-10Thommen Medical, AGSPI ELEMENT Platform O 4.0 MmNHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K070007
K0615782006-12-26Specialty Spine Products, LLCSSP Vertebral Body ReplacementMQPOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K061578
K0630702006-12-14Cayenne Medical, Inc.AperFix Tibial Implant With InserterHWCOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K063070
K0624872006-11-17Cayenne Medical, Inc.AperFix Femoral Implant With InserterHWZOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K062487
K0614102006-09-08Zimmer Dental Inc.Screw-Vent Implant System, Sv;Tapered Screw -Vent Implant System, Tsv;Advent Implant System,Av;Zimmer One-Piece ImplantDZEDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K061410
K0613352006-08-09Coastal BiocareEnhance Dental Implant SystemDZE, NHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K061335
K0612662006-07-31Ortho Organizers, Inc.Ortho Organizers Temporary Orthodontic AnchorOATDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K061266
K0618072006-07-31Thommen Medical, AGSPI Art AbutmentsNHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K061807
K0517042006-07-03Showa Ika Kohgyo Co.,Ltd.MYKRES Spinal SystemKWP, MNHOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K051704
K0601182006-06-08Specialty Spine Products, LLCSSP Pedicle Screw SystemMNI, MNHOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K060118
K0533842006-03-24Astra TechFixture MicroThread OsseoSpeedDZEDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K053384
K0528472005-12-12X-Spine Systems, Inc.Capless Pedicle Screw SystemMNI, MNHOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K052847
K0520612005-10-21Medartis, Inc.MODUS IMF Screws 2.0DZEDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K052061
K0518592005-09-23S.I.N. - Sistema De Implante Nacional LtdaSistema De Implante Nacional (S.I.N.); Dental Implant SystemNHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K051859
K0515672005-08-23Medartis, Inc.APTUS® Titanium Osteosynthesis SystemHRSDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K051567
K0519462005-08-22Medartis, Inc.MODUS Modular Distraction Osteogenesis SystemMQNDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K051946
K0515272005-07-28Thommen Medical, AGSPI EASY Temporary CapNHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K051527
K0515022005-06-21Thommen Medical, AGSPI Dental ImplantDZEDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K051502
K0507892005-05-27R And D Medical, LlcFormagraft Collagen Bone Graft MatrixMQVOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K050789
K0509342005-05-05Medartis, Inc.MODUS Titanium Osteosynthesis SystemJEYDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K050934
K0427152005-03-23Titan Implants, Inc.Titan Dental Implant AttachmentNHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K042715
K0500252005-02-03Angstrom Medica, Inc.Nanoss Bone Void FillerMQVOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K050025
K0429712005-01-14Titan Implants, Inc.Titan Dental Implant SystemDZEDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K042971
K0404932004-09-03Orthopedic Sciences, IncOutologous Spinal Fixation SystemMNI, MNHOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K040493
K0408502004-06-24Orthopedic Sciences, IncTSY Shoulder Plate ImplantHRSOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K040850
K0336992004-04-22Zest Anchors, LLCLocator Bar Female, Locator Laser Bar Female, Locator Bar Cast-To Female, Models 08587, 08588, 08586DZEDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K033699
K0340142004-03-05Thommen Medical, AGSPI CONTACT Dental ImplantDZEDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K034014
K0333462003-11-03Thommen Medical, AGSPI EASYDental Implant Protective CapNHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K033346
K0313192003-07-17Aspine USA, Inc.Osteo-G Bone Void Filler SystemMQVOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K031319
K0317472003-07-02Thommen Medical, AGSPI Dental Implant AbutmentsNHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K031747
K0306892003-03-26Thommen Medical, AGSPI ELEMENT Dental Implant O 3.5 MmDZEDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K030689
K0236452002-11-13Thommen Medical, AGSPI EASY Dental Implant AbutmentNHA, DZEDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K023645
K0221392002-09-23Orthopedic Sciences, IncHip Tool ImplantHRSOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K022139
K0220382002-07-15PaxMed InternationalSPI ONETIME Dental ImplantDZEDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K022038
K0205542002-05-03Kinetikos Medical, Inc.Modification to Universal Total Wrist SystemJWJOpthalmichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K020554
K0000352001-09-28Omnicare Dental Implant CenterOmnicare Dental Implant SystemDZEDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K000035
K0104672001-09-28PaxMed InternationalUniversal Dental Coping (UDC)DZEDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K010467
K0115742001-09-28Universal Implant Systems, Inc.Uniplant Dental Implant SystemDZEDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K011574
K0022412001-09-20Quantum Bioengineering, Ltd.Quantum Versatility (QVS) Dental Implant SystemDZEDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K002241
K0112232001-09-20Quantum Bioengineering, Ltd.Quantum Versatility (QVS) Dental Implant SystemDZEDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K011223
K0033382001-02-07Integrated Orbital Implants, Inc.Bio-Eye II Orbital ImplantHPZ, MTZOpthalmichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K003338
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K0013372000-07-05The Daniels Corp.Daniels Sharpsmart Reusable Sharps ContainerMHKGeneral Hospitalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K001337
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K9729131998-07-30Pacific Materials and InterfacesMacroPore Protective Sheet (Protego System)HRS, HWCOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K972913
K9806091998-05-18Metagen, LLCSegmental Defect Replacement SystemHSBOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K980609
K9800201998-04-03Metagen, LLCActiveLock Modular Femoral Hip SystemLPH, JDI, MEHOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K980020
K9742031998-02-04Integrated Orbital Implants, Inc.Perry-Kolberg (PK) Titanium Motility/Support SystemMQUOpthalmichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K974203
K9723271997-08-11Pacific Materials and InterfacesMetagen ActiveLock Cerclage SystemJDQOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K972327