SYNTHES STERILE MANDIBLE EXTERNAL FIXATION KIT

SYNTHES STERILE MANDIBLE EXTERNAL FIXATION KIT is an FDA 510(k)-cleared medical device (K062299) manufactured by Synthes (Usa). This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 30, 2006. Regulation: 8.