INTERMEDICS APR(TM) II FEMORAL COMPONENT

INTERMEDICS APR(TM) II FEMORAL COMPONENT is an FDA 510(k)-cleared medical device (K890450) manufactured by Intermedics Orthopedics. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 8, 1989. Regulation: 8.