510(k) K182783

DePuy Synthes Trauma Orthopedic Nail Implants by DePuy Synthes — Product Code HRS

K182783 is an FDA 510(k) premarket notification submitted by DePuy Synthes for the device "DePuy Synthes Trauma Orthopedic Nail Implants". The FDA issued a decision of Substantially Equivalent on December 26, 2018. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. DePuy Synthes has at least 10 other 510(k) clearances on record.