510(k) K974331

UNI-ROM TOTAL HIP SYSTEM FEMORAL STEM by Johnson & Johnson Professionals, Inc. — Product Code LPH

K974331 is an FDA 510(k) premarket notification submitted by Johnson & Johnson Professionals, Inc. for the device "UNI-ROM TOTAL HIP SYSTEM FEMORAL STEM". The FDA issued a decision of Substantially Equivalent on February 6, 1998. 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. Johnson & Johnson Professionals, Inc. has at least 10 other 510(k) clearances on record.