510(k) K071053

RECAP HA PRESS-FIT FEMORAL RESURFACING HEAD by Biomet, Inc. — Product Code KXA

K071053 is an FDA 510(k) premarket notification submitted by Biomet, Inc. for the device "RECAP HA PRESS-FIT FEMORAL RESURFACING HEAD". The FDA issued a decision of Substantially Equivalent on June 29, 2007. The device falls under product code KXA (Prosthesis, Hip, Femoral, Resurfacing), a Class II device regulated under 21 CFR 888.3400. Biomet, Inc. has at least 10 other 510(k) clearances on record.