THE UNIVERSAL CEMENT PLUG(TM)

THE UNIVERSAL CEMENT PLUG(TM) is an FDA 510(k)-cleared medical device (K910135) manufactured by Biotron , Ltd.. 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 4, 1991. Regulation: 8.