Mariner Pedicle Screw System

Mariner Pedicle Screw System is an FDA 510(k)-cleared medical device (K160902) 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 May 25, 2016. Regulation: 8.