Device details
FDA 510(k) registration fields
- K number
- K251282
- Device name
- StealthStation S8 Spine Software
- Company
- Medtronic Navigation, Inc.
- Country / Region
- United States(US)
- Product code
- OLO
- Device class
- Class 2
- Regulation number
- 21 CFR 882.4560
- Date received
- 2025-04-24
- Decision date
- 2025-10-17
- Submission type
- Traditional
- Technology type
- Software Navigation(AI inferred)
- Clinical applications
- Spine SurgeryNavigation System
- Primary application
- Spine Surgery
- Classification source
- AI classified
