510(k) K021799

CEMENTED FEMORAL HEAD RESURFING DEVICE by Biomet Orthopedics, Inc. — Product Code KXA

K021799 is an FDA 510(k) premarket notification submitted by Biomet Orthopedics, Inc. for the device "CEMENTED FEMORAL HEAD RESURFING DEVICE". The FDA issued a decision of Substantially Equivalent on June 26, 2002. The device falls under product code KXA (Prosthesis, Hip, Femoral, Resurfacing), a Class II device regulated under 21 CFR 888.3400. Biomet Orthopedics, Inc. has at least 10 other 510(k) clearances on record.