APR FEMORAL HIP COMPONENT

APR FEMORAL HIP COMPONENT is an FDA 510(k)-cleared medical device (K930812) manufactured by Intermedics Orthopedics. 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 16, 1993. Regulation: 8.