AIS Odontoid Fracture Fixation System

AIS Odontoid Fracture Fixation System is an FDA 510(k)-cleared medical device (K142707) manufactured by Aesculap Implant System, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 18, 2014. Regulation: 8.