510(k) K121714

SMITH & NEPHEW, INC. SHOULDER SYSTEM INSTRUMENTS by Smith & Nephew, Inc. — Product Code HSD

K121714 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Inc. for the device "SMITH & NEPHEW, INC. SHOULDER SYSTEM INSTRUMENTS". The FDA issued a decision of Substantially Equivalent on September 7, 2012. The device falls under product code HSD (Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented), a Class II device regulated under 21 CFR 888.3690. Smith & Nephew, Inc. has at least 10 other 510(k) clearances on record.