Stealth AXiS Cranial clinical application

Stealth AXiS Cranial clinical application is an FDA 510(k)-cleared medical device (K253379) 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 March 25, 2026. Regulation: 8.