Stealthstation S8 Spine Software v1.3.0

Stealthstation S8 Spine Software v1.3.0 is an FDA 510(k)-cleared medical device (K201189) manufactured by Medtronic Navigation, Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 28, 2020. Regulation: 8.