SeaSpine 7D Navigation Instruments

SeaSpine 7D Navigation Instruments is an FDA 510(k)-cleared medical device (K222753) manufactured by SeaSpine Orthopedics Corporation. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 8, 2022. Regulation: 8.