INTER-OP DURASUL ACETABULAR INSERTS/COCR FEMORAL HEADS

INTER-OP DURASUL ACETABULAR INSERTS/COCR FEMORAL HEADS is an FDA 510(k)-cleared medical device (K993259) manufactured by Sulzer Orthopedics, 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 March 9, 2000. Regulation: 8.