510(k) K163651

ExpressBraid Graft Manipulation by Biomet Manufacturing Corp — Product Code GAT

K163651 is an FDA 510(k) premarket notification submitted by Biomet Manufacturing Corp for the device "ExpressBraid Graft Manipulation". The FDA issued a decision of Substantially Equivalent on February 17, 2017. The device falls under product code GAT (Suture, Nonabsorbable, Synthetic, Polyethylene), a Class II device regulated under 21 CFR 878.5000. Biomet Manufacturing Corp has at least 10 other 510(k) clearances on record.