510(k) K071887

SPORTMESH OR ARTELON TISSUE REINFORCEMENT by Artimplant AB — Product Code FTL

K071887 is an FDA 510(k) premarket notification submitted by Artimplant AB for the device "SPORTMESH OR ARTELON TISSUE REINFORCEMENT". The FDA issued a decision of Substantially Equivalent on September 18, 2007. The device falls under product code FTL (Mesh, Surgical, Polymeric), a Class II device regulated under 21 CFR 878.3300. Artimplant AB has at least 6 other 510(k) clearances on record.