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Category Archives: News

PaxMed at ASTM Meetings in November

PaxMed International is an active participant in the work of international standards consensus standards bodies, including ASTM, the American Dental Association and ISO. Floyd Larson, PaxMed’s President, chairs ISO and ADA committees and serves as Membership Secretary for ASTM Committee F04 on Medical and Surgical Materials and Devices. Floyd will be in Atlanta, Georgia from November 13-16 […]

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Meet PaxMed’s President at NASS 2017

Floyd Larson, President of PaxMed International, will be at the 32nd North American Spine Society Annual Meeting in Orlando, Florida on October 26 and 27, 2017. If you have questions about how to navigate the regulatory system in the United States or Europe, and want to know more about how PaxMed may be able to help you […]

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PaxMed Announces the FDA Clearance of New Thommen Implant System Components

For immediate release, October 6, 2017: PaxMed International announces FDA 510(k) clearance, on behalf of Thommen Medical AG of Grenchen, Switzerland, of the ELEMENT Ø 3.0 self-tapping, root form, endosseous dental implant and abutments. ELEMENT Ø 3.0 is a self-tapping, root form, endosseous dental implant made of commercially pure titanium, available in two surfaces (TST and INICELL) and five […]

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PaxMed Announces the FDA Clearance of New Components for the Medartis APTUS® Wrist 2.5 System

For immediate release, September 19, 2017: PaxMed International announces FDA 510(k) clearance, on behalf of Medartis AG of Basel, Switzerland, of new plates for the APTUS® Wrist 2.5 System. This clearance adds four plate designs to expand the range of Medartis APTUS® upper extremity fixation devices. It includes two anatomic designs each for the left and […]

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PaxMed Announces the FDA Clearance of DESS Dental Smart Solutions abutments

For immediate release August 8, 2017: PaxMed International, LLC on behalf of Terrats Medical SL of Montcada i Reixac, Spain, announces the clearance of DESS Dental Smart Solutions 510(k). DESS Dental Smart Solutions is a dental implant abutment system that includes seven abutment design types (Healing, Temporary, Straight, TiBase, Pre-milled Blank, DESS LOC, Multi-Unit), and ten abutment connections compatible with […]

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FDA 510(k) user fees increase by as much as 125%

Small Business qualification is more important than ever! Establishment Registration Fee increases by more than a third (to $4,624). In order for a 510(k) submitter to avoid a large increase in the FDA User Fee starting October 1, 2017, it will be very important that a request for Small Business determination (SBD) be submitted well […]

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PaxMed Announces the FDA Clearance of ReBOSSIS85

For Immediate Release, June 23, 2017: PaxMed International, LLC announces, on behalf of Orthorebirth Co., Ltd. of Yokohama, Japan, the 510(k) clearance of ReBOSSIS85, synthetic, resorbable bone void filler. It is a composite material consisting of (by weight) 40% beta-tricalcium phosphate (β-TCP), 30% siloxane-containing vaterite (a form of calcium carbonate, CaCO3), and 30% poly(L-lactide-co-glycolide). The […]

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PaxMed Announces the FDA Clearance of NovoGro Putty from OsteoNovus

April 18, 2017 – PaxMed proudly announces the FDA 510(k) clearance of NovoGro moldable bone substitute putty, on behalf of its manufacturer, OsteoNovus, of Toledo, Ohio. NovoGro Putty is a breakthrough bone regeneration biomaterial with excellent handling properties. It is intended for use as a bone void filler for gaps and voids that are not […]

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Meet with PaxMed as the American Academy of Orthopedic Surgeons gathers in San Diego

Dr. Kevin Thomas will attend the 2017 Annual Meeting of the American Academy of Orthopedic Surgeons (AAOS), in PaxMed’s backyard in San Diego. Kevin will meet with clients and new friends as they visit our city. If you would like to meet with Kevin to explore how PaxMed can help you achieve marketing clearance or […]

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Meet with PaxMed at the Academy of Osseointegration in Orlando

Floyd Larson and Linda Schulz will attend the 2017 Annual Meeting of the Academy of Osseointegration in Orlando, Florida, from March 15 to 18. They will meet with clients and other friends, including new friends who may need PaxMed’s services to navigate the increasingly complex regulatory environment of the FDA and international regulatory bodies. If […]

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