SYNTHES (USA) ORIBITAL MESH PLATES

SYNTHES (USA) ORIBITAL MESH PLATES is an FDA 510(k)-cleared medical device (K001311) manufactured by Synthes (Usa). This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 19, 2000. Regulation: 8.