DOLOMITE Anterior Cervical Stabilization System

DOLOMITE Anterior Cervical Stabilization System is an FDA 510(k)-cleared medical device (K202065) manufactured by Astura Medical, LLC. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 25, 2020. Regulation: 8.