Mariner MIS Pedicle Screw System; SeaSpine Navigation System

Mariner MIS Pedicle Screw System; SeaSpine Navigation System is an FDA 510(k)-cleared medical device (K191648) 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 July 18, 2019. Regulation: 8.