VALEO C Spacer System 11.002.1609
VALEO C Spacer System 11.002.1609 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 19 Sep 2023 (UDI-DI 00841732155817), 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 | Number00841732155817 | Date19 Sep 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK091278 | Date28 Jan 2010 | StatusActive |
Official records
- AccessGUDID record 00841732155817
- FDA 510(k) database K091278
Across registries
- FDA 510(k) K091278 decided 28 Jan 2010 Active
- FDA GUDID UDI-DI 00841732155817 listed 19 Sep 2023 Listed
Timeline
- Cleared FDA 510(k) K091278
- Listed FDA GUDID 00841732155817
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- VALEO C Spacer System
- Generic name
- Ceramic spinal interbody fusion cage
- Model / reference
- 11.002.1609
- Primary DI / UDI-DI
- 00841732155817
- 510(k) Number
- FDA product code
- ODP
- GMDN term
- Ceramic spinal interbody fusion cage
- Device class
- Class II
- Regulation number
- 888.3080
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code ODP (Intervertebral Fusion Device With Bone Graft, Cervical).
- Mecta-C Cervical Ti-Peek Cages 03.28.701 by Medacta International SA
- 4-WEB Cervical Sts (Spinal Truss System) by 4WEB INC.
- Mecta-C Ti mark 03.28.325 by Medacta International SA
- Endoskeleton TC by Titan Spine, Inc.
- ShurFit CpTi-HA ACIF Interbody Fusion System by Precision Spine, Inc.
- VARILIFT -C by Wenzel Spine
- VARILIFT CERVICAL INTERBODY FUSION SYSTEM by Wenzel Spine
- Perimeter C (Titanium) Spinal System by MEDTRONIC SOFAMOR DANEK, INC.
- Cervical Interbody and VBR Fusion System by Sync Surgical
- Phantom Plus Cage System by Us Spine