510(k) K043542

BIOPRO TARA FEMORAL RESURFACING COMPONENT by Biopro, Inc. — Product Code KXA

K043542 is an FDA 510(k) premarket notification submitted by Biopro, Inc. for the device "BIOPRO TARA FEMORAL RESURFACING COMPONENT". The FDA issued a decision of Substantially Equivalent on May 18, 2005. The device falls under product code KXA (Prosthesis, Hip, Femoral, Resurfacing), a Class II device regulated under 21 CFR 888.3400. Biopro, Inc. has at least 10 other 510(k) clearances on record.