DURACON STABILIZER FEMORAL COMPONENT AND INSERT

DURACON STABILIZER FEMORAL COMPONENT AND INSERT is an FDA 510(k)-cleared medical device (K932070) 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 March 21, 1995. Regulation: 8.