CervAlign® Anterior Cervical Plate System

CervAlign® Anterior Cervical Plate System is an FDA 510(k)-cleared medical device (K211408) manufactured by Pioneer Surgical Technology, Inc.. 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 22, 2021. Regulation: 8.