SMITH & NEWPHEW ULTRABRAID II SUTURE

SMITH & NEWPHEW ULTRABRAID II SUTURE is an FDA 510(k)-cleared medical device (K101377) manufactured by Smith & Newphew, Inc.. 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 April 7, 2011. Regulation: 8.