510(k) K061253

REFLECTION 3 ACETABULAR SYSTEM by Smith & Nephew, Inc. — Product Code MBL

K061253 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Inc. for the device "REFLECTION 3 ACETABULAR SYSTEM". The FDA issued a decision of Substantially Equivalent on May 31, 2006. 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.