510(k) K120871

SMITH & NEPHEW, INC. EXTERNAL FIXATION SYSTEM INSTRUMENTATION by Smith & Nephew, Inc. — Product Code JDW

K120871 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Inc. for the device "SMITH & NEPHEW, INC. EXTERNAL FIXATION SYSTEM INSTRUMENTATION". The FDA issued a decision of Substantially Equivalent on June 7, 2012. The device falls under product code JDW (Pin, Fixation, Threaded), a Class II device regulated under 21 CFR 888.3040. Smith & Nephew, Inc. has at least 10 other 510(k) clearances on record.