DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATION

DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATION is an FDA 510(k)-cleared medical device (K980925) manufactured by Howmedica 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 15, 1998. Regulation: 8.