SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone System

SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone System is an FDA 510(k)-cleared medical device (K190655) 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 April 28, 2019. Regulation: 8.