SOVEREIGN® Spinal System

SOVEREIGN® Spinal System is an FDA 510(k)-cleared medical device (K162680) 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 December 13, 2016. Regulation: 8.