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Medtronic Sofamor Danek USA, Inc.
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THREADED CEMENT RESTRICTOR (CR) TITANIUM is an FDA 510(k)-cleared medical device (K011443) manufactured by Medtronic Sofamor Danek USA, Inc.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 2, 2001. Regulation: 8.