StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1

StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1 is an FDA 510(k)-cleared medical device (K190672) 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 July 30, 2019. Regulation: 8.