510(k) K960094

REFLECTION DUAL DIMENSION SHELL by Smith & Nephew Richards, Inc. — Product Code MBL

K960094 is an FDA 510(k) premarket notification submitted by Smith & Nephew Richards, Inc. for the device "REFLECTION DUAL DIMENSION SHELL". The FDA issued a decision of Substantially Equivalent on March 27, 1996. 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 Richards, Inc. has at least 10 other 510(k) clearances on record.