DURACON ALL PLASTIC TIBIAL COMPONENT

DURACON ALL PLASTIC TIBIAL COMPONENT is an FDA 510(k)-cleared medical device (K922048) 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 September 7, 1992. Regulation: 8.