SYNTHES (USA) EXTERNAL MULTI VECTOR MANDIBLE DISTRACTOR

SYNTHES (USA) EXTERNAL MULTI VECTOR MANDIBLE DISTRACTOR is an FDA 510(k)-cleared medical device (K981362) 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 June 28, 1998. Regulation: 8.