510(k) K964150

WHITESIDE BIOMECHANICS ZIRCONIA CERAMIC FEMORAL HEAD by Whiteside Biomechanics, Inc. — Product Code LZO

K964150 is an FDA 510(k) premarket notification submitted by Whiteside Biomechanics, Inc. for the device "WHITESIDE BIOMECHANICS ZIRCONIA CERAMIC FEMORAL HEAD". The FDA issued a decision of Substantially Equivalent on December 27, 1996. The device falls under product code LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented), a Class II device regulated under 21 CFR 888.3353. Whiteside Biomechanics, Inc. has at least 10 other 510(k) clearances on record.