HYDROXYAPATITE COATED PROFILE(R) HIP STEM

HYDROXYAPATITE COATED PROFILE(R) HIP STEM is an FDA 510(k)-cleared medical device (K910156) manufactured by Depuy, 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 June 6, 1991. Regulation: 8.