VALEO TL Spacer System 91.001.3507
VALEO TL Spacer System 91.001.3507 is a Class II device made by CTL Medical Corporation, cleared under FDA 510(k) K091278 on 28 Jan 2010 and listed in FDA GUDID since 27 Sep 2023 (UDI-DI 00841732162570), 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 | Number00841732162570 | Date27 Sep 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK091278 | Date28 Jan 2010 | StatusActive |
Official records
- AccessGUDID record 00841732162570
- FDA 510(k) database K091278
Across registries
- FDA 510(k) K091278 decided 28 Jan 2010 Active
- FDA GUDID UDI-DI 00841732162570 listed 27 Sep 2023 Listed
Timeline
- Cleared FDA 510(k) K091278
- Listed FDA GUDID 00841732162570
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- VALEO TL Spacer System
- Generic name
- Spinal implant trial
- Model / reference
- 91.001.3507
- Primary DI / UDI-DI
- 00841732162570
- 510(k) Number
- FDA product code
- MAX
- GMDN term
- Spinal implant trial
- Device class
- Class II
- Regulation number
- 888.3080
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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