CADENCE PEEK CEMEENT RESTRICTOR

CADENCE PEEK CEMEENT RESTRICTOR is an FDA 510(k)-cleared medical device (K023647) 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 November 26, 2002. Regulation: 8.