K253381
- 510(k) number
- K253381
- Device name
- Stealth AXiS Surgical System with Stealth AXiS Spine clinical application
- Applicant
- Medtronic Navigation, Inc. CO · US
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2026-02-12
- Date received
- 2025-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K253381.pdf
Official FDA record: K253381
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.