SUTURTEK FASTCLOSE STERNUM CLOSURE DEVICE

SUTURTEK FASTCLOSE STERNUM CLOSURE DEVICE is an FDA 510(k)-cleared medical device (K032468) manufactured by Suturtek Incorporated. 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 September 22, 2003. Regulation: 8.