Tyber Medical’s PEEK ToeGrip Hammer Toe Implant Family Receives MDR Certification

September 10, 2024
3:02 pm

BETHLEHEM, Pa., Sept. 10, 2024 /PRNewswire/ -- Tyber Medical LLC, a leading orthopedic device manufacturer specializing in private label implants for the extremity, trauma, and spine markets, is proud to announce that its PEEK ToeGrip Hammer Toe implant family has received Medical Device Regulation (MDR) certification from TÜV Rheinland. This prestigious certification marks the first time a hammer toe implant has achieved both FDA 510(k) clearance and MDR certification, setting a new standard for orthopedic implants.

The ToeGrip family, which includes the ToeGrip Classic, ToeGrip Evo, and ToeGrip Retrograde, offers versatile solutions for hammer toe deformities. The ToeGrip Retrograde, designed specifically for the U.S. market, allows for additional K-Wire fixation to enhance stability.

These implants have demonstrated success in clinical settings, having been used in over 55,000 patients with a clinical history spanning more than 14 years. The proven clinical experience and efficacy of the ToeGrip implants underscore Tyber Medical’s commitment to advancing patient care and delivering innovative solutions that meet the highest regulatory standards.

Tyber Medical’s PEEK ToeGrip Hammer Toe Implant Family Receives MDR Certification

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