Neurology
Stealth AXiS Surgical System with Stealth AXiS Spine clinical application
Medtronic Navigation, Inc.
FDA
FDA-cleared AI medical device
Stereotaxic guidance during orthopedic surgery procedures. Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW.
FDA Submission Metadata
- Submission number
- K253381
- Decision date
- February 2026
- FDA panel
- Neurology
- Product code
- OLO
This entry is sourced from the FDA AI/ML-Enabled Medical Devices list. No editorial review yet — the catalogue may add a deeper review of this device in future.
Regulatory Approvals
FDA
US FDA 510k
K253381
This entry is on our editorial review queue. Full evaluation — performance metrics, clinical evidence, safety record — lands as our review pipeline graduates each device. The information above is what's been verified to date.