510(k) K062408

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

K062408 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Inc. for the device "SMITH & NEPHEW MODULAR FEMORAL (HEMI) HEAD". The FDA issued a decision of Substantially Equivalent on September 12, 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.