
Medtronic Sofamor Danek, Inc.
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MASTERGRAFT RESORBABLE CERAMIC is an FDA 510(k)-cleared medical device (K020986) manufactured by Medtronic Sofamor Danek, 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 July 21, 2002. Regulation: 8.