510(k) K021549

CONTOURED ARTICULAR PROSTHESIS (CAP) FEMORAL HEAD RESURFACING SYSTEM by Std Mfg., Inc. — Product Code KXA

K021549 is an FDA 510(k) premarket notification submitted by Std Mfg., Inc. for the device "CONTOURED ARTICULAR PROSTHESIS (CAP) FEMORAL HEAD RESURFACING SYSTEM". The FDA issued a decision of Substantially Equivalent on August 1, 2002. The device falls under product code KXA (Prosthesis, Hip, Femoral, Resurfacing), a Class II device regulated under 21 CFR 888.3400. Std Mfg., Inc. has at least 5 other 510(k) clearances on record.