510(k) K180310

DePuy Synthes Trauma Orthopedic Plates and Screws by Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. — Product Code HRS

K180310 is an FDA 510(k) premarket notification submitted by Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. for the device "DePuy Synthes Trauma Orthopedic Plates and Screws". The FDA issued a decision of Substantially Equivalent on November 1, 2018. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. has at least 4 other 510(k) clearances on record.