510(k) K040756

THE TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 10-340-XXXXX by Implex Corp. — Product Code FTM

K040756 is an FDA 510(k) premarket notification submitted by Implex Corp. for the device "THE TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 10-340-XXXXX". The FDA issued a decision of Substantially Equivalent on July 14, 2004. The device falls under product code FTM (Mesh, Surgical), a Class II device regulated under 21 CFR 878.3300. Implex Corp. has at least 10 other 510(k) clearances on record.