510(k) K061243

SMITH & NEPHEW MODULAR FEMORAL HEAD by Smith & Nephew, Inc. — Product Code KWL

K061243 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Inc. for the device "SMITH & NEPHEW MODULAR FEMORAL HEAD". The FDA issued a decision of Substantially Equivalent on July 17, 2006. The device falls under product code KWL (Prosthesis, Hip, Hemi-, Femoral, Metal), a Class II device regulated under 21 CFR 888.3360. Smith & Nephew, Inc. has at least 10 other 510(k) clearances on record.