VALEO II PL OL Interbody Fusion System 12.301.2007
VALEO II PL OL Interbody Fusion System 12.301.2007 is a Class II device made by CTL Medical Corporation, cleared under FDA 510(k) K121892 on 24 Aug 2012 (1 earlier submission) and listed in FDA GUDID since 27 Sep 2023 (UDI-DI 00841732156135), 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 | Number00841732156135 | Date27 Sep 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK121892 | Date24 Aug 2012 | StatusActive |
Official records
- AccessGUDID record 00841732156135
- FDA 510(k) database K121892
- FDA 510(k) database K082801
Across registries
- FDA 510(k) K121892 decided 24 Aug 2012 Active
- FDA GUDID UDI-DI 00841732156135 listed 27 Sep 2023 Listed
Timeline
- Cleared FDA 510(k) K082801
- Cleared FDA 510(k) K121892
- Listed FDA GUDID 00841732156135
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- VALEO II PL OL Interbody Fusion System
- Generic name
- Ceramic spinal interbody fusion cage
- Model / reference
- 12.301.2007
- Primary DI / UDI-DI
- 00841732156135
- FDA product code
- MAX
- GMDN term
- Ceramic spinal interbody fusion cage
- Device class
- Class II
- Regulation number
- 888.3080
- GUDID distribution status
- In Commercial Distribution
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