THEKEN LARGE CEMENT RESTRICTOR

THEKEN LARGE CEMENT RESTRICTOR is an FDA 510(k)-cleared medical device (K012462) manufactured by Theken Surgical,Llc. 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 October 28, 2001. Regulation: 8.