SOVEREIGN™ Spinal System

SOVEREIGN™ Spinal System is an FDA 510(k)-cleared medical device (K172328) manufactured by Medtronic Sofamor Danek USA, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 1, 2017. Regulation: 8.