26 MM CAST COCR HEAD AND POLYETHYLENE ACETABULAR SHELL LINER

26 MM CAST COCR HEAD AND POLYETHYLENE ACETABULAR SHELL LINER is an FDA 510(k)-cleared medical device (K991622) 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 July 13, 1999. Regulation: 8.