510(k) K964616

QUATROLOC PLASMA SPRAYED FEMORAL COMPONENT by Whiteside Biomechanics, Inc. — Product Code LPH

K964616 is an FDA 510(k) premarket notification submitted by Whiteside Biomechanics, Inc. for the device "QUATROLOC PLASMA SPRAYED FEMORAL COMPONENT". The FDA issued a decision of Substantially Equivalent on August 7, 1997. The device falls under product code LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented), a Class II device regulated under 21 CFR 888.3358. Whiteside Biomechanics, Inc. has at least 10 other 510(k) clearances on record.