Uni-Thread® L2-C548T
Uni-Thread® L2-C548T 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 03663136004730), 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 | Number03663136004730 | Date15 Oct 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK013301 | Date13 Feb 2002 | StatusActive |
Official records
- AccessGUDID record 03663136004730
- FDA 510(k) database K013301
Across registries
- FDA 510(k) K013301 decided 13 Feb 2002 Active
- FDA GUDID UDI-DI 03663136004730 listed 15 Oct 2015 Listed
Timeline
- Cleared FDA 510(k) K013301
- Listed FDA GUDID 03663136004730
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- Withdrawn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-C548T
- Primary DI / UDI-DI
- 03663136004730
- 510(k) Number
- FDA product code
- MNI, MNH
- 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
Similar devices in this category
Other devices filed under Spinal bone screw, non-bioabsorbable.
- Sterile Posterior Spinal Fixation System SR-C221-55080 by Shanghai Reach Medical Instrument Co., Ltd
- Mecta-C Cervical Plate System 03.70.412 by Medacta International SA
- AccelFix Spinal Fixation System (Sterile) 8102-85140S by L&K Biomed
- AccelFix Spinal Fixation System (Sterile) 8102-8045S by L&K Biomed
- KHEIRON 24PW55055 by S.M.A.I.O
- GSST-0702-2008-CE(4) by GS Medical Co., Ltd.