Dark Star Navigation 102001-40
Dark Star Navigation 102001-40 (DSN-40T) is a Class II device made by Republic Spine, LLC, cleared under FDA 510(k) K212028 on 27 Sep 2021 and listed in FDA GUDID since 14 May 2026 (UDI-DI B075102001400), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberB075102001400 | Date14 May 2026 | StatusListed |
| United States | FDA 510(k)SESE | NumberK212028 | Date27 Sep 2021 | StatusActive |
Official records
- FDA 510(k) database K212028
Across registries
- FDA 510(k) K212028 decided 27 Sep 2021 Active
- FDA GUDID UDI-DI B075102001400 listed 14 May 2026 Listed
Timeline
- Cleared FDA 510(k) K212028
- Listed FDA GUDID B075102001400
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Dark Star Navigation
- Generic name
- General internal orthopaedic fixation system implantation kit
- Model / Ref / Catalog
- 102001-40, DSN-40T
- Primary DI / UDI-DI
- B075102001400
- 510(k) Number
- FDA product code
- OLO
- GMDN term
- General internal orthopaedic fixation system implantation kit
- Device class
- Class II
- Regulation number
- 882.4560
- GUDID distribution status
- Not in Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
- MRI safety
- MR Unsafe
- Size
- Outer Diameter — 4.0 Millimeter