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Globus Medical, Inc.
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FORTIFY(TM) AND FORTIFY(TM)-R CORPECTOMY SPACERS is an FDA 510(k)-cleared medical device (K112756) manufactured by Globus Medical, 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 October 6, 2011. Regulation: 8.