510(k) K012193

AMC ANTIMICROBIAL PIN/WIRE SLEEVE by Smith & Nephew, Inc. — Product Code JEC

K012193 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Inc. for the device "AMC ANTIMICROBIAL PIN/WIRE SLEEVE". The FDA issued a decision of Substantially Equivalent on July 11, 2002. The device falls under product code JEC (Component, Traction, Invasive), a Class II device regulated under 21 CFR 888.3040. Smith & Nephew, Inc. has at least 10 other 510(k) clearances on record.