Shoreline ACS Interbody System; Shoreline RT Interbody System

Shoreline ACS Interbody System; Shoreline RT Interbody System is an FDA 510(k)-cleared medical device (K233414) 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 November 27, 2023. Regulation: 8.