Tyber Medical BioTy(TM) Nanotopography Trauma Screw, TyFix Screw

Tyber Medical BioTy(TM) Nanotopography Trauma Screw, TyFix Screw is an FDA 510(k)-cleared medical device (K170571) manufactured by Tyber Medical, LLC. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 19, 2017. Regulation: 8.