510(k) K172830

Double Medical Femoral Nail System by Double Medical Technology, Inc. — Product Code HSB

K172830 is an FDA 510(k) premarket notification submitted by Double Medical Technology, Inc. for the device "Double Medical Femoral Nail System". The FDA issued a decision of Substantially Equivalent on August 24, 2018. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020. Double Medical Technology, Inc. has at least 10 other 510(k) clearances on record.