SYNTHES (USA) NEW/STERIAL ORBITAL PLATES

SYNTHES (USA) NEW/STERIAL ORBITAL PLATES is an FDA 510(k)-cleared medical device (K031761) 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 September 2, 2003. Regulation: 8.