SeaSpine NewPort Spinal System

SeaSpine NewPort Spinal System is an FDA 510(k)-cleared medical device (K180176) 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 February 19, 2018. Regulation: 8.