RPX TITANIUM CEMNT RESTRICTOR

RPX TITANIUM CEMNT RESTRICTOR is an FDA 510(k)-cleared medical device (K020344) manufactured by Sulzer Spine-Tech. 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 1, 2002. Regulation: 8.