Mandible External Fixator - MR Conditional

Mandible External Fixator - MR Conditional is an FDA 510(k)-cleared medical device (K143285) 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 May 27, 2015. Regulation: 8.