510(k) K023188

PRESS-FIT HEAD RESURFACING DEVICE by Biomet Orthopedics, Inc. — Product Code KXA

K023188 is an FDA 510(k) premarket notification submitted by Biomet Orthopedics, Inc. for the device "PRESS-FIT HEAD RESURFACING DEVICE". The FDA issued a decision of Substantially Equivalent on December 11, 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.