StealthStation S8 Cranial v2.0

StealthStation S8 Cranial v2.0 is an FDA 510(k)-cleared medical device (K212397) manufactured by Medtronic Navigation. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 21, 2021. Regulation: 8.