DePuy Synthes Maxillofacial Portfolio - MR Conditional

DePuy Synthes Maxillofacial Portfolio - MR Conditional is an FDA 510(k)-cleared medical device (K183113) manufactured by Synthes (USA) Products, LLC. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 12, 2019. Regulation: 8.