510(k) K092386

R3 MULTI-HOLE SHELLS AND 36MM XLPE ACETABULAR LINERS by Smith & Nephew, Inc. — Product Code MBL

K092386 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Inc. for the device "R3 MULTI-HOLE SHELLS AND 36MM XLPE ACETABULAR LINERS". The FDA issued a decision of Substantially Equivalent on November 3, 2009. The device falls under product code MBL (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous), a Class II device regulated under 21 CFR 888.3358. Smith & Nephew, Inc. has at least 10 other 510(k) clearances on record.