Shoreline Threaded TruProfile® Plate

Shoreline Threaded TruProfile® Plate is an FDA 510(k)-cleared medical device (K211903) 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 August 29, 2021. Regulation: 8.