510(k) K150769

Cardinal Health Trochanteric IM Nail System by Cardinalhealth — Product Code HSB

K150769 is an FDA 510(k) premarket notification submitted by Cardinalhealth for the device "Cardinal Health Trochanteric IM Nail System". The FDA issued a decision of Substantially Equivalent on December 14, 2015. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020. Cardinalhealth has at least 10 other 510(k) clearances on record.