Uni-Thread® L2-C828T
Uni-Thread® L2-C828T is a Class II device made by Spine Vision, Inc., cleared under FDA 510(k) K013301 on 13 Feb 2002 and listed in FDA GUDID since 15 Oct 2015 (UDI-DI 03663136004907), active as of 22 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 | Number03663136004907 | Date15 Oct 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK013301 | Date13 Feb 2002 | StatusActive |
Official records
- AccessGUDID record 03663136004907
- FDA 510(k) database K013301
Across registries
- FDA 510(k) K013301 decided 13 Feb 2002 Active
- FDA GUDID UDI-DI 03663136004907 listed 15 Oct 2015 Listed
Timeline
- Cleared FDA 510(k) K013301
- Listed FDA GUDID 03663136004907
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Uni-Thread®
- Generic name
- Spinal bone screw, non-bioabsorbable
- Model / reference
- L2-C828T
- Primary DI / UDI-DI
- 03663136004907
- 510(k) Number
- FDA product code
- MNH, MNI
- GMDN term
- Spinal bone screw, non-bioabsorbable
- Device class
- Class II
- Regulation number
- 888.3070
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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