510(k) K192702

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

K192702 is an FDA 510(k) premarket notification submitted by Synthes (USA) Products, LLC for the device "DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional". The FDA issued a decision of Substantially Equivalent on September 18, 2020. The device falls under product code GXN (Plate, Cranioplasty, Preformed, Non-Alterable), a Class II device regulated under 21 CFR 882.5330. Synthes (USA) Products, LLC has at least 10 other 510(k) clearances on record.