MEDTRONIC SOFAMOR DANEK CEMENT RESTRICTOR

MEDTRONIC SOFAMOR DANEK CEMENT RESTRICTOR is an FDA 510(k)-cleared medical device (K012255) manufactured by Medtronic Sofamor Danek, 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 July 31, 2001. Regulation: 8.