Tyber Medical Receives FDA 510(k) Clearance for TyFix

By Julie A. Vetalice

Tyber Medical received FDA 510(k) clearance for the TyFix™ all-in-one extremity fixation system. By integrating the implant and instruments, TyFix eliminates the use of ancillary instrumentation for a range of bone fixation procedures, including hammertoe correction.

The sterile-packed system includes the TyFix Screw, which combines an optimized bone thread with a barbed head to maximize bone purchase and compression in proximal and distal phalanges.

Source: Tyber Medical LLC

Product Labels: Upper Extremity, Lower Extremity

Tags: 510(k) Clearance, Regulatory