OMNIFIT(R) TOTAL KNEE SYSTEM (MODIFICATION)

OMNIFIT(R) TOTAL KNEE SYSTEM (MODIFICATION) is an FDA 510(k)-cleared medical device (K871769) 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 June 1, 1987. Regulation: 8.