DURACON MONOLITHIC STABILIZER FEMORAL COMPONENT

DURACON MONOLITHIC STABILIZER FEMORAL COMPONENT is an FDA 510(k)-cleared medical device (K954138) 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 November 20, 1995. Regulation: 8.