Tyber Medical BioTy® Nanotopography Trauma Screw

Tyber Medical BioTy® Nanotopography Trauma Screw is an FDA 510(k)-cleared medical device (K161597) 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 November 15, 2016. Regulation: 8.