510(k) K221221

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

K221221 is an FDA 510(k) premarket notification submitted by Double Medical Technology, Inc. for the device "Advanced Intramedullary Nail System". The FDA issued a decision of Substantially Equivalent on December 21, 2022. 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.