SeaSpine® NewPort™ Spinal System

SeaSpine® NewPort™ Spinal System is an FDA 510(k)-cleared medical device (K161535) 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 September 7, 2016. Regulation: 8.