Device details
FDA 510(k) registration fields
- K number
- K242933
- Device name
- SPINEART Navigation Instrument System
- Company
- Spineart SA
- Country / Region
- Switzerland(CH)
- Product code
- OLO
- Device class
- Class 2
- Regulation number
- 21 CFR 882.4560
- Date received
- 2024-09-25
- Decision date
- 2025-06-18
- Submission type
- Traditional
