MAXBRAID POLYESTER PLUS AND POLYETHYLENE PLUS SUTURE

MAXBRAID POLYESTER PLUS AND POLYETHYLENE PLUS SUTURE is an FDA 510(k)-cleared medical device (K033718) manufactured by Arthrotek, 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 February 11, 2004. Regulation: 8.