APR FULLY TEXTURED HIP STEM

APR FULLY TEXTURED HIP STEM is an FDA 510(k)-cleared medical device (K961589) 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 July 8, 1996. Regulation: 8.