SeaSpine Shoreline ACS - Anterior Cervical Standalone System

SeaSpine Shoreline ACS - Anterior Cervical Standalone System is an FDA 510(k)-cleared medical device (K170569) 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 June 14, 2017. Regulation: 8.