Leaders in Regulatory Affairs for the Medical Device Industry

Category Archives: News

Meet with PaxMed as the American Academy of Orthopedic Surgeons in New Orleans

Join us at the 2018 Annual Meeting of the American Academy of Orthopedic Surgeons (AAOS), in New Orleans, March 7-10. If you would like to meet with us to explore how PaxMed can help you achieve marketing clearance or approval, please call PaxMed at (858) 792-1235, or send an email message to Carolyn Poirier at […]

Read More

PaxMed Announces the FDA Clearance of Dentium Ti-Base

January 11, 2018: PaxMed International is happy to announce 510(k) clearance of Dentium Ti-Base, on behalf of Dentium Co., Ltd of the Republic of Korea. Dentium Ti-Base abutments are used for support of direct crowns/bridges or for support of CAD/CAM fabricated zirconia copings manufactured by a Dentium validated milling center. The new abutments are compatible with the Dentium […]

Read More

Meet PaxMed March 1-3 at the Academy of Osseointegration 2018 Annual Meeting

Join Founder and President of PaxMed International, Floyd Larson and Senior Regulatory Specialist, Linda Schulz at this year’s Academy of Osseointegration Annual Meeting, March 1-3 at the Los Angeles Convention Center. Digital dentistry is a major topic of discussion among AO attendees, and PaxMed has extensive experience in shepherding digital dentistry products for dental implants through the FDA approval […]

Read More

PaxMed closes out 2017 with its 202nd FDA 510(k) clearance – ORTHOReBIRTH’s ReBOSSIS85 for Posterolateral Spine

December 15, 2017: PaxMed International announces that it closed out a productive 2017 with the FDA 510(k) clearance of K172573 for ReBOSSIS85 resorbable bone void filler, on behalf of Orthorebirth Co., Ltd. of Yokohama, Japan. This submission expands the cleared indications for use of REBOSSIS85 to the posterolateral spine as a bone graft extender. The subject device […]

Read More

PaxMed Obtains its 201st FDA 510(k) Clearance – Biomet 3i TSV BellaTek Encode Healing Abutment

December 13, 2017: PaxMed International announces the beginning of its next hundred FDA 510(k) clearances, with Number 201, on behalf of Biomet 3i of Palm Beach Gardens, Florida, part of the Zimmer Biomet Dental Division. FDA 510(k) clearance of K173374 for TSV BellaTek Encode Healing Abutments brings the proven BellaTek Encode abutment system to the Zimmer […]

Read More

PaxMed Celebrates 200 510(k) Clearances

December 1, 2017 For Immediate Release: PaxMed today is celebrating our 200th FDA 510(k) clearance for our clients. The clearance that marks Number 200 is K170392, for S.I.N. – Sistema de Implante Nacional S.A., of São Paulo, Brazil. The clearance includes four Morse taper product line additions to the S.I.N. Dental Implant System: Unitite Slim, Unitite, Unitite Compact and Strong SW […]

Read More

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 […]

Read More

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 […]

Read More

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 […]

Read More

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 […]

Read More