Shoreline ACS (Anterior Cervical System)

Shoreline ACS (Anterior Cervical System) is an FDA 510(k)-cleared medical device (K201646) manufactured by SeaSpine Orthopedics Corporation. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 13, 2020. Regulation: 8.