510(k) K033329

DEPUY ACE UNIVERSAL AND TROCH ENTRY FEMORAL NAIL SYSTEMS by Depuy, Inc. — Product Code HSB

K033329 is an FDA 510(k) premarket notification submitted by Depuy, Inc. for the device "DEPUY ACE UNIVERSAL AND TROCH ENTRY FEMORAL NAIL SYSTEMS". The FDA issued a decision of Substantially Equivalent on November 14, 2003. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020. Depuy, Inc. has at least 10 other 510(k) clearances on record.