DePuy Synthes Craniomaxillofacial Sternal Devices - MR Conditional

DePuy Synthes Craniomaxillofacial Sternal Devices - MR Conditional is an FDA 510(k)-cleared medical device (K190963) manufactured by Synthes (USA) Products, LLC. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 22, 2019. Regulation: 8.