
Theken Surgical,Llc
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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.