OMNIFIT ZIRCONIA C-TAPER FEMORAL BEARING HEAD

OMNIFIT ZIRCONIA C-TAPER FEMORAL BEARING HEAD is an FDA 510(k)-cleared medical device (K925695) manufactured by Osteonics Corp.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 19, 1993. Regulation: 8.