510(k) K020170

KEYSTONE HIP SYSTEM CALCAR REPLACEMENT BODY AND BUILD UP by Encore Orthopedics, Inc. — Product Code LPH

K020170 is an FDA 510(k) premarket notification submitted by Encore Orthopedics, Inc. for the device "KEYSTONE HIP SYSTEM CALCAR REPLACEMENT BODY AND BUILD UP". The FDA issued a decision of Substantially Equivalent on February 11, 2002. 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. Encore Orthopedics, Inc. has at least 10 other 510(k) clearances on record.