CEMSTOP CEMENT RESTRICTOR

CEMSTOP CEMENT RESTRICTOR is an FDA 510(k)-cleared medical device (K993841) manufactured by Encore Orthopedics, 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 May 3, 2000. Regulation: 8.