510(k) K190963

DePuy Synthes Craniomaxillofacial Sternal Devices - MR Conditional by Synthes (USA) Products, LLC — Product Code HRS

K190963 is an FDA 510(k) premarket notification submitted by Synthes (USA) Products, LLC for the device "DePuy Synthes Craniomaxillofacial Sternal Devices - MR Conditional". The FDA issued a decision of Substantially Equivalent on July 23, 2019. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Synthes (USA) Products, LLC has at least 10 other 510(k) clearances on record.