OMNIFIT TOTAL KNEE PROSTHESIS SYSTEM

OMNIFIT TOTAL KNEE PROSTHESIS SYSTEM is an FDA 510(k)-cleared medical device (K862837) 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 December 21, 1986. Regulation: 8.