510(k) K961625

QUATROLOC FEMORAL COMPONENT & HEAD by Whiteside Biomechanics, Inc. — Product Code LPH

K961625 is an FDA 510(k) premarket notification submitted by Whiteside Biomechanics, Inc. for the device "QUATROLOC FEMORAL COMPONENT & HEAD". The FDA issued a decision of Substantially Equivalent on September 10, 1996. 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.