APR POROUS HA HIP SYSTEM

APR POROUS HA HIP SYSTEM is an FDA 510(k)-cleared medical device (K973124) manufactured by Sulzer Orthopedics, Inc.. 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 2, 1997. Regulation: 8.