510(k) K921525

HIP JOINT METAL/POLYMER SEMI-CONSTRAINED PROTHESIS by Implant Technology, Inc. — Product Code LPH

K921525 is an FDA 510(k) premarket notification submitted by Implant Technology, Inc. for the device "HIP JOINT METAL/POLYMER SEMI-CONSTRAINED PROTHESIS". The FDA issued a decision of Substantially Equivalent on January 11, 1995. 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. Implant Technology, Inc. has at least 10 other 510(k) clearances on record.