SPINAL USA CEMENT RESTRICTOR SYSTEM

SPINAL USA CEMENT RESTRICTOR SYSTEM is an FDA 510(k)-cleared medical device (K060132) manufactured by Spinal USA. 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 March 15, 2006. Regulation: 8.