NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System

NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System is an FDA 510(k)-cleared medical device (K203129) manufactured by Precision Spine, 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 11, 2021. Regulation: 8.