22 MM COCR HEAD & POLYETHLENE LINER

22 MM COCR HEAD & POLYETHLENE LINER is an FDA 510(k)-cleared medical device (K960180) manufactured by Stelkast Company. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 1, 1996. Regulation: 8.