510(k) K030151

CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEM by Hayes Medical, Inc. — Product Code LZO

K030151 is an FDA 510(k) premarket notification submitted by Hayes Medical, Inc. for the device "CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEM". The FDA issued a decision of Substantially Equivalent on April 10, 2003. 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. Hayes Medical, Inc. has at least 10 other 510(k) clearances on record.