SYNTHES TRANSLATING MAXILLARY DISTRACTOR

SYNTHES TRANSLATING MAXILLARY DISTRACTOR is an FDA 510(k)-cleared medical device (K020505) 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 April 22, 2002. Regulation: 8.