CervAlign™ Anterior Cervical Plate System

CervAlign™ Anterior Cervical Plate System is an FDA 510(k)-cleared medical device (K183060) manufactured by Pioneer Surgical Technology, Inc. (Dba Rti Surgical, 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 January 16, 2019. Regulation: 8.