Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4

Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4 is an FDA 510(k)-cleared medical device (K221087) 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 June 9, 2022. Regulation: 8.