OMNIFIT TOTAL KNEE SERIES II TIBIAL INSERTS

OMNIFIT TOTAL KNEE SERIES II TIBIAL INSERTS is an FDA 510(k)-cleared medical device (K884398) 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 January 16, 1989. Regulation: 8.