MODIFICATION TO FORTITUDE CEMENT RESTRICTOR

MODIFICATION TO FORTITUDE CEMENT RESTRICTOR is an FDA 510(k)-cleared medical device (K031837) manufactured by Spinal Concepts, 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 23, 2003. Regulation: 8.