510(k) K080434

INTERTAN CHS LOCKING PLATE SYSTEM PROX FEM PLATES/SCREW by Smith & Nephew, Inc. — Product Code JDO

K080434 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Inc. for the device "INTERTAN CHS LOCKING PLATE SYSTEM PROX FEM PLATES/SCREW". The FDA issued a decision of Substantially Equivalent on April 10, 2008. The device falls under product code JDO (Device, Fixation, Proximal Femoral, Implant), a Class II device regulated under 21 CFR 888.3030. Smith & Nephew, Inc. has at least 10 other 510(k) clearances on record.