PaxMed has helped clients achieve over 200 510(k) clearances to date.

The list below will give you an idea of the scope of our 510(k) work. Click the + for more information from the FDA website.

K Number
Company
Product Name
Product Code
Branch
FDA Link
K0717434th ColumnPillar Pedicle Screw SystemMNI, MNHOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K071743
K082180AngelusPerma Fiber /Perma MeshEBIDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K082180
K112046AngelusMTA AngelusKIFDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K112046
K113568AngelusMTA FillapexKIFDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K113568
K050025Angstrom Medica, Inc.Nanoss Bone Void FillerMQVOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K050025
K031319Aspine USA, Inc.Osteo-G Bone Void Filler SystemMQVOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K031319
K053384Astra TechFixture MicroThread OsseoSpeedDZEDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K053384
K063779Astra TechOsseoSpeed 4.0s-6mm, Model 24619DZEDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K063779
K072624Astra TechAstra Tech Implant System, New ComponentNHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K072624
K080156Astra TechOsseoSpeed Profile SystemDZE, NHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K080156
K080396Astra TechOsseoSpeed NarrowDZE, NHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K080396
K091239Astra TechAstra Tech Implant SystemDZEDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K091239
K101005Astra TechAstra Tech Implant System, New ComponentNHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K101005
K101732Astra TechAstra Tech Implant SystemDZEDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K101732
K111287Astra TechAstra Tech Implant SystemDZE, NHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K111287
K113424Astra TechLoFric® Pobe CatheterEZODentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K113424
K120414Astra TechOsseoSpeed PlusDZEDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K120414
K121810Astra TechOsseoSpeed Angled EvNHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K121810
K122078Astra TechLoFric® PrimoTM and LoFric® Hydro-KitTMEZDUrologyhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K122078
K063205Atlas Spine LLCAtlas Spine Vertebral Body ReplacementMQPOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K063205
K083858Augma BiomaterialsBond BoneLYCOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K083858
K121177Augma BiomaterialsBond ApatiteLYCOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K121177
K071638BioHorizonsBioHorizons Tapered Internal Implant SystemDZE, NHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K071638
K173374Biomet 3iTSV BellaTek Encode Healing AbutmentsNHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K173374
K092541BiostructuresInterface (Extremity, Alone)MQVOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K092541
K112857BiostructuresInterface Bone Void FillerMQVOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K112857
K153064Blue Sky BioBlue Sky Bio Zygomatic Implant SystemDZE, NHADentalhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K153064
K081157CagenixAccuframeNHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K081157
K071213CamlogCAMLOG Logfit Prosthetic SystemNHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K071213
K073553CamlogCAMLOG Implant System AbutmentsNHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K073553
K083496CamlogCAMLOG Implant System Modified Implants And AbutmentsDZE, NHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K083496
K090347CamlogCAMLOG Abutments PSNHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K090347
K103252CamlogCAMLOG Vario SR AbutmentsNHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K103252
K113779CamlogCONELOGDZE, NHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K113779
K133991CamlogiSy SystemDZE, NHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K133991
K143337CamlogCONELOG® Titanium Base CAD/CAMNHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K143337
K151599CamlogiSy® Implant SystemDZE, NHADentalhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K151599
K152509CamlogCAMLOG® and CONELOG® Abutments For Screw-retained Restorations (ASR)NHADentalhttp://www.accessdata.fda.gov/cdrh_docs/pdf15/K152509.pdf
K153779CamlogAbutment for BridgesNHADentalhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K153779
K160784CamlogCAM Titanium BlanksNHADentalhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K160784
K100698Cardinal SpineSTCCODPOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K100698
K121176Cardinal SpineSTGCMQPOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K121176
K142030Cardinal SpineSTGC-LordoticMQPOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K142030
K152568Cardinal SpineC-VBRPLROrthopedichttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K152568
K062487Cayenne Medical, Inc.AperFix Femoral Implant With InserterHWZOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K062487
K063070Cayenne Medical, Inc.AperFix Tibial Implant With InserterHWCOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K063070
K071796Cayenne Medical, Inc.Capsew Plication SystemGATOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K071796
K073054Cayenne Medical, Inc.Modification To AperFix Femoral Implant With InserterHWCOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K073054
K120176CentrixSenzzzzz AwayLBHDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K120176
K061335Coastal BiocareEnhance Dental Implant SystemDZE, NHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K061335
K082058CookDynaMatrixNPLDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K082058
K103431CorentecCOREN Total Hip SystemLPHOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K103431
K110404CorentecEAUMTotal Knee SystemJWHOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K110404
K181721Curasan AGCeracell Ortho FoamMQVOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K181721
K132792Daniels SharpsmartEcoship Disposable SharpsMMKGeneral Hospitalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K132792
K083543DenovisDenovisMed Dental Implant SystemsDZE, NHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K083543
K161713Dentium Co., LtdDentium CAD/CAM AbutmentsNHADentalhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K161713
K171622Dentium Co., LtdDentium Ti-BaseNHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K171622
K130216Dentsply ImplantAtlantis Abutment for Straumann BLNHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K130216
K130999Dentsply ImplantOsseoSpeed Profile EvDZE, NHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K130999
K182246Imagine Milling TechnologidsMIST ICNHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K182246
K180924Integrated Dental SystemsReflect™ Implant SystemDCA, NHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K180924
K000151Integrated Orbital Implants, Inc.Perry-Kolberg (PK) Ha-Coated Titanium SleeveMQUOpthalmichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K000151
K003338Integrated Orbital Implants, Inc.Bio-Eye II Orbital ImplantHPZ, MTZOpthalmichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K003338
K974203Integrated Orbital Implants, Inc.Perry-Kolberg (PK) Titanium Motility/Support SystemMQUOpthalmichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K974203
K071070KeystoneOlympus Dental Implant SystemDZE, NHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K071070
K020554Kinetikos Medical, Inc.Modification to Universal Total Wrist SystemJWJOpthalmichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K020554
K063794LDR Spine USAModification to Easyspine SystemMNI, MNHOpthalmichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K063794
K994158MacroPore Biosurgery, Inc.MacroSorbOS Protective SheetHRS, HWC, MAIOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K994158
K101426Mathys LtdCeros TCP GranulesLYCDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K101426
K071612Medartis, AGMODUS Trilock 2.0/2.3/2.5JEYDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K071612
K090053Medartis, AGAPTUS® 2.0 Radial Head SystemHRS, HWCOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K090053
K090983Medartis, AGAPTUS® 2.0/2.3 Four Corner Fusion PlateHRSOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K090983
K091479Medartis, AGAPTUS® Foot SystemHRS, HWCOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K091479
K092038Medartis, AGAPTUS® K-Wire SystemHTYOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K092038
K102537Medartis, AGAPTUS® 1.5 TrilockHRSOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K102537
K103332Medartis, AGAPTUS® Ulna PlatesHRS, HWCOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K103332
K110658Medartis, AGAPTUS® Cannulated Compression ScrewsHWCOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K110658
K110908Medartis, AGAPTUS® Foot 3.5 SystemHRS, HWCOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K110908
K112169Medartis, AGAPTUS® Wrist Arthrodesis PlatesHRSOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K112169
K112560Medartis, AGAPTUS® Distal Humerus SystemHRS, HWCOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K112560
K120108Medartis, AGAPTUS® Proximal HumerusHRSOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K120108
K133460Medartis, AGAPTUS® Cannulated Screws 5, 7HWC, HTYOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K133460
K141232Medartis, AGAPTUS® Ulna Shortening 2.5HRS, HWCOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K141232
K142581Medartis, AGAPTUS® Foot SystemHRS, HWCOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K142581
K142906Medartis, AGAPTUS® Wrist 2.5 SystemHRS, HWCOrthopedichttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K142906
K161861Medartis, AGAPTUS® Coronoid 2.0HRSOrthopedichttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K161861
K172170Medartis, AGAPTUS® Wrist 2.5 SystemHRSOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K172170
K181009Medartis, AGAPTUS® CMC-I Fusion SystemHRSOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K181009
K181425Medartis, AGAPTUS® Proximal Humerus SystemHRS, HTY, HWCOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K181425
K050934Medartis, Inc.MODUS Titanium Osteosynthesis SystemJEYDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K050934
K051567Medartis, Inc.APTUS® Titanium Osteosynthesis SystemHRSDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K051567
K051946Medartis, Inc.MODUS Modular Distraction Osteogenesis SystemMQNDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K051946
K052061Medartis, Inc.MODUS IMF Screws 2.0DZEDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K052061
K142167Medentika GmbHMedentika Abutment SystemNHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K142167
K150203Medentika GmbHCAD/CAM AbutmentsNHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K150203
K980020Metagen, LLCActiveLock Modular Femoral Hip SystemLPH, JDI, MEHOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K980020
K980609Metagen, LLCSegmental Defect Replacement SystemHSBOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K980609
K110442NanovisNanovis Intervertebral Body Fusion SystemODP, MAXOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K110442
K131345NasseoTiArray Dental Implant SystemDZE, NHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K131345
K121117National DentexNDX Custom AbutmentsNHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K121117
K101207NeodentNeodent Implant SystemDZEDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K101207
K101945NeodentNeodent Implant SystemDZE, NHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K101945
K102769NeodentNeodent Implant SystemOATDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K102769
K103084NeodentNeodent Implant SystemDZLDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K103084
K123022NeodentNeodent Implant SystemDZE, NHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K123022
K133510NeodentNeodent Implant SystemDZE, NHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K133510
K133696NeodentNeodent Implant SystemNHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K133696
K141777NeodentNeodent Implant SystemDZE, NHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K141777
K150199NeodentNeodent Implant SystemDZE, NHADentalhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K150199
K150367NeodentNeodent Implant SystemNHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K150367
K171713NeodentNeodent Instrument KitsKCTDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K171713
K173902NeodentNeodent Implant System - GM LineNHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K173902
K180536NeodentGM Line AdditionsDZEDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K180536
K102641NeoorthoMini and Micro Fragments Reconstruction System-NeofaceJEYDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K102641
K113733NeoorthoSmall and Large Fragments Osteosynthesis System NEOFIXHRS, HWCOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K113733
K141103NeoorthoItramedullary Nails and Screws NEONAILHSBOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K141103
K142419Neoortho Produtos Ortopedicos S/AMini and Micro Fragments Reconstruction NEOFIXHRS, HWCOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K142419
K122198Oco BiomedicalI Macro 6.0mm X 6.0mm ImplantDZEDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K122198
K000035Omnicare Dental Implant CenterOmnicare Dental Implant SystemDZEDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K000035
K983120Oraltronics Marketing-Und Vertriebs GmbhBicortical ScrewDZEDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K983120
K061266Ortho Organizers, Inc.Ortho Organizers Temporary Orthodontic AnchorOATDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K061266
K022139Orthopedic Sciences, IncHip Tool ImplantHRSOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K022139
K040493Orthopedic Sciences, IncOutologous Spinal Fixation SystemMNI, MNHOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K040493
K040850Orthopedic Sciences, IncTSY Shoulder Plate ImplantHRSOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K040850
K133018Orthopedic Sciences, IncOSI Q System ArthoscopesHRXOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K133018
K142090Orthorebirth Co., LtdReBOSSISMQVOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K142090
K170620Orthorebirth Co., LtdREBOSSIS85MQVOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K170620
K172573Orthorebirth Co., LtdReBOSSIS85MQVOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K172573
K073685Osseous Technology of AmericaOTA Collagen BiomaterialNPLOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K073685
K162087OsteoNovus, Inc. NovoGroMQVOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K162087
K173525OsteoNovus, Inc. NovoGroMQVOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K173525
K133827OsteoVasiveA-Link Z IVB Fusion DeviceOVDOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K133827
K972327Pacific Materials and InterfacesMetagen ActiveLock Cerclage SystemJDQOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K972327
K972913Pacific Materials and InterfacesMacroPore Protective Sheet (Protego System)HRS, HWCOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K972913
K983360Pacific Materials and InterfacesMacroPore Protective SheetJEYDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K983360
K010467PaxMed InternationalUniversal Dental Coping (UDC)DZEDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K010467
K022038PaxMed InternationalSPI ONETIME Dental ImplantDZEDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K022038
K071500PentronNano-Bond II Adhesive SystemKLEDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K071500
K091031Pioneer Surgical TechnologyPioneer Surgical Nanoss BVF-EMQVOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K091031
K100361Pioneer Surgical TechnologyNanoss Bone Void Filler (Fortross Syringe)MQVOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K100361
K110561Pioneer Surgical TechnologyFortrOss Bone Void FillerMQVOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K110561
K111944Pioneer Surgical TechnologyNB3D Bone Void FillerMQVOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K111944
K081460Pou Yu Biotechnology Co, LtdTDS AbutmentNHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K081460
K183518Preat CorporationEndosseous Dental Implant AbutmentNHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K183518
K160979Prismatik Dentalcraft, Inc.Inclusive® AbutmentsNHADentalhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K160979
K002241Quantum Bioengineering, Ltd.Quantum Versatility (QVS) Dental Implant SystemDZEDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K002241
K011223Quantum Bioengineering, Ltd.Quantum Versatility (QVS) Dental Implant SystemDZEDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K011223
K112279Quantum Bioengineering, Ltd.Quantum™ Dental Implant SystemDZE, NHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K112279
K130787Quantum Bioengineering, Ltd.Quantum™ Dental Implant SystemDZEDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K130787
K050789R And D Medical, LlcFormagraft Collagen Bone Graft MatrixMQVOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K050789
K110965RenovisRenovis T 710 Large External Fixation SystemKTTOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K110965
K120038RenovisA200 Knee SystemJWHOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K120038
K143694Rhondium, Ltd.One-Visit-CrownEBFDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K143694
K162677Rhondium, Ltd.L-OVCEIHDentalhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K162677
K160786Rodo Medical, Inc. Rodo Abutment SystemNHADentalhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K160786
K051859S.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
K170392S.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
K170398S.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
K051704Showa Ika Kohgyo Co.,Ltd.MYKRES Spinal SystemKWP, MNHOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K051704
K071074Showa Ika Kohgyo Co.,Ltd.MYKRES Spinal SystemKWP, KWQ, MNHOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K071074
K153274Snyder Industries, Inc.Med-Tainer Single Deposit Container (SDC)MMKGeneral Hospitalhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K153274
K163634Southern Implants (Pty) Ltd.External Hex ImplantsDZE, NHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K163634
K173343Southern Implants (Pty) Ltd.Zygomatic Implant SystemDZEDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K173343
K180465Southern Implants (Pty) Ltd.Provata Implant SystemDZE, NHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K180465
K181850Southern Implants (Pty) Ltd.Inversa ImplantsDZEDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K181850
K060118Specialty Spine Products, LLCSSP Pedicle Screw SystemMNI, MNHOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K060118
K061578Specialty Spine Products, LLCSSP Vertebral Body ReplacementMQPOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K061578
K092082Synergy Surgical TechnologiesSynergy Cannulated Screw SystemHTNOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K092082
K170588Terrats Medical SLDESS Dental Smart SolutionsNHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K170588
K173908Terrats Medical SLDESS Dental Smart SolutionsNHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K173908
K001337The Daniels Corp.Daniels Sharpsmart Reusable Sharps ContainerMHKGeneral Hospitalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K001337
K023645Thommen Medical, AGSPI EASY Dental Implant AbutmentNHA, DZEDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K023645
K030689Thommen Medical, AGSPI ELEMENT Dental Implant O 3.5 MmDZEDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K030689
K031747Thommen Medical, AGSPI Dental Implant AbutmentsNHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K031747
K033346Thommen Medical, AGSPI EASYDental Implant Protective CapNHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K033346
K034014Thommen Medical, AGSPI CONTACT Dental ImplantDZEDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K034014
K051502Thommen Medical, AGSPI Dental ImplantDZEDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K051502
K051527Thommen Medical, AGSPI EASY Temporary CapNHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K051527
K061807Thommen Medical, AGSPI Art AbutmentsNHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K061807
K070007Thommen Medical, AGSPI ELEMENT Platform O 4.0 MmNHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K070007
K070290Thommen Medical, AGSPI VECTODRILL Ceramic DrillsNDPDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K070290
K071453Thommen Medical, AGSPI EASY 4.0 AbutmentNHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K071453
K072649Thommen Medical, AGSPI System Dental ImplantsDZEDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K072649
K072856Thommen Medical, AGSPI VARIOmulti AbutmentNHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K072856
K072933Thommen Medical, AGSPI Contact Platform O 4.0 MmDZE, NHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K072933
K073141Thommen Medical, AGSPI Art AbutmentNHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K073141
K090153Thommen Medical, AGSPI VARIOmulti Angled AbutmentNHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K090153
K090154Thommen Medical, AGSPI Dental Implant InicellDZEDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K090154
K092248Thommen Medical, AGSPI Customizable Gingiva FormerNHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K092248
K093615Thommen Medical, AGSPI Dental Implant, ElementDZEDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K093615
K101798Thommen Medical, AGSPI VARIOmulti Angled AbutmentNHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K101798
K102804Thommen Medical, AGSPI Titanium Base For Cad/CamNHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K102804
K111984Thommen Medical, AGSPI VARIO Angled AbutmentNHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K111984
K121334Thommen Medical, AGVARIOecoNHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K121334
K151984Thommen Medical, AGMilling Abutment for CAD/CAMNHADentalhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K151984
K160244Thommen Medical, AGVARIOunite NHADentalhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K160244
K171795Thommen Medical, AGThommen Implant SystemDZE, NHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K171795
K042715Titan Implants, Inc.Titan Dental Implant AttachmentNHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K042715
K042971Titan Implants, Inc.Titan Dental Implant SystemDZEDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K042971
K151916Tri Dental Implants Int. AGTRI® Dental Implant SystemDZE, NHADentalhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K151916
K070295Trinity Orthopedics, LLCSingle Planar Multi Axial (SPMA) Pedicle Screw SystemMNI, MNHOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K070295
K081790Trinity Orthopedics, LLCModification to SPMA Pedicle Screw SystemMNI, MNHOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K081790
K011574Universal Implant Systems, Inc.Uniplant Dental Implant SystemDZEDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K011574
K180204Visionare, LLCCranioMaxillofacial Fixation (CMF) System - CMF VisionareJEY, DZLOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K180204
K123751Wellspect HealthcareLoFric® SenseEZDUrologyhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K123751
K052847X-Spine Systems, Inc.Capless Pedicle Screw SystemMNI, MNHOrthopedichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K052847
K062542Z-SystemsZ-Look3 Dental Implant System, Model Z3-XXXDZEDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K062542
K120793Z-SystemsZ-Look3 Evo SLMDZEDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K120793
K131701Z-SystemsZ5 Mlb MlcDZEDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K131701
K132881Z-SystemsZ5cDZE, NHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K132881
K150021Z-SystemsZ5m(t)DZEDentalhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K150021
K033699Zest 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
K133327Zest Anchors, LLCSaturno Overdenture Implant SystemDZEDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K133327
K140570Zest Anchors, LLCChairside Attachment Processing MaterialEBIDentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K140570
K150295Zest Anchors, LLCLOCATOR RTxNHADentalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K150295
K151789Zest Anchors, LLCLOCATOR F-Tx Attachment SystemNHADentalhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K151789
K061410Zimmer 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