510(k) K021466

CONSENSUS ACETABULAR INSERT, CROSS-LINKED POLYETHYLENE by Hayes Medical, Inc. — Product Code LPH

K021466 is an FDA 510(k) premarket notification submitted by Hayes Medical, Inc. for the device "CONSENSUS ACETABULAR INSERT, CROSS-LINKED POLYETHYLENE". The FDA issued a decision of Substantially Equivalent on July 24, 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. Hayes Medical, Inc. has at least 10 other 510(k) clearances on record.