P.C.A.PRIMARY HIP- CEMENTLESS USE

P.C.A.PRIMARY HIP- CEMENTLESS USE is an FDA 510(k)-cleared medical device (K945092) manufactured by Howmedica Corp.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 18, 1995. Regulation: 8.