510(k) K033718

MAXBRAID POLYESTER PLUS AND POLYETHYLENE PLUS SUTURE by Arthrotek, Inc. — Product Code GAT

K033718 is an FDA 510(k) premarket notification submitted by Arthrotek, Inc. for the device "MAXBRAID POLYESTER PLUS AND POLYETHYLENE PLUS SUTURE". The FDA issued a decision of Substantially Equivalent on February 12, 2004. The device falls under product code GAT (Suture, Nonabsorbable, Synthetic, Polyethylene), a Class II device regulated under 21 CFR 878.5000. Arthrotek, Inc. has at least 10 other 510(k) clearances on record.