510(k) K111352

TALON DISTALFIX PROXIMAL FEMORAL NAIL by Orthopedic Designs North America, Inc. — Product Code HSB

K111352 is an FDA 510(k) premarket notification submitted by Orthopedic Designs North America, Inc. for the device "TALON DISTALFIX PROXIMAL FEMORAL NAIL". The FDA issued a decision of Substantially Equivalent on Aug 22, 2011. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020. Orthopedic Designs North America, Inc. has 3 other 510(k) clearances on record.