VALEO C Spacer System 11.009.2010
VALEO C Spacer System 11.009.2010 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 00841732154704), 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 | Number00841732154704 | Date19 Sep 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK091278 | Date28 Jan 2010 | StatusActive |
Official records
- AccessGUDID record 00841732154704
- FDA 510(k) database K091278
Across registries
- FDA 510(k) K091278 decided 28 Jan 2010 Active
- FDA GUDID UDI-DI 00841732154704 listed 19 Sep 2023 Listed
Timeline
- Cleared FDA 510(k) K091278
- Listed FDA GUDID 00841732154704
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- Withdrawn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
- 11.009.2010
- Primary DI / UDI-DI
- 00841732154704
- 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).
- ARENA-C TIFUSE CERVICAL INTERVERTEBRAL BODY FUSION DEVICE by SPINEFRONTIER, INC.
- NANOVIS INTERVERTEBRAL BODY FUSION SYSTEM by Nanovis, LLC
- C-PS PEEK OPTIMA CERVICAL INTERBODY SPACER, L-PS PEEK OPTIMA LUMBAR INTERBODY SPACER by RSB SPINE LLC.
- Mecta-C Ti mark 03.28.327 by Medacta International SA
- TALOS-C CERVICAL INTERVERTEBRAL BODY FUSION DEVICES by Meditech Advisors, LLC
- Mecta-C Cervical Ti-Peek Cages 03.28.727 by Medacta International SA
- MAXIM SURGICAL X-TREME INTERBODY FUSION SYSTEM by Maxim Surgical
- Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody Fusion Device and Endoskeleton® TCS Interbody Fusion Device by Titan Spine, Inc.
- nvc by NVISION BIOMEDICAL TECHNOLOGIES, INC
- IDYS-C® ZP 3DTi 43707016 by Clariance, Inc.