510(k) K963509

GLOBAL TAPER TAPERED HIP SYSTEM, GT SPECTRON by Smith & Nephew Richards, Inc. — Product Code LPH

K963509 is an FDA 510(k) premarket notification submitted by Smith & Nephew Richards, Inc. for the device "GLOBAL TAPER TAPERED HIP SYSTEM, GT SPECTRON". The FDA issued a decision of Substantially Equivalent on January 27, 1997. 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. Smith & Nephew Richards, Inc. has at least 10 other 510(k) clearances on record.