Craniomaxillofacial Distraction System (CMFD)

Craniomaxillofacial Distraction System (CMFD) is an FDA 510(k)-cleared medical device (K170818) manufactured by Synthes USA Products, LLC. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 6, 2017. Regulation: 8.