510(k) K152295

Talon DistalFix Antegrade/Retrograde Femoral Nail by Orthopedic Designs North America, Inc. — Product Code HSB

K152295 is an FDA 510(k) premarket notification submitted by Orthopedic Designs North America, Inc. for the device "Talon DistalFix Antegrade/Retrograde Femoral Nail". The FDA issued a decision of Substantially Equivalent on Nov 3, 2015. 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.