CEMENT RESTRICTOR FOR PROFORMA AND PERFECTA TOTAL

CEMENT RESTRICTOR FOR PROFORMA AND PERFECTA TOTAL is an FDA 510(k)-cleared medical device (K923909) manufactured by Orthomet, 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 November 3, 1992. Regulation: 8.