APR II NON-POROUS HIP STEM

APR II NON-POROUS HIP STEM is an FDA 510(k)-cleared medical device (K913208) 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 October 10, 1991. Regulation: 8.