DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION

DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION is an FDA 510(k)-cleared medical device (K980632) 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 10, 1998. Regulation: 8.