Skyway Anterior Cervical Plate System

Skyway Anterior Cervical Plate System is an FDA 510(k)-cleared medical device (K250486) manufactured by Kyocera Medical Technologies Inc. (KMTI). This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 9, 2025. Regulation: 8.