
Sulzer Orthopedics, Inc.
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NATURAL-KNEE II SYSTEM COCR TIBIAL BASEPLATE is an FDA 510(k)-cleared medical device (K021578) 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 August 8, 2002. Regulation: 8.