X-Pac SV2453
X-Pac SV2453 is a Class II device made by Spine View, Inc., cleared under FDA 510(k) K152539 on 24 Feb 2016 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00853954003241), 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 | Number00853954003241 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK152539 | Date24 Feb 2016 | StatusActive |
Official records
- AccessGUDID record 00853954003241
- FDA 510(k) database K152539
Across registries
- FDA 510(k) K152539 decided 24 Feb 2016 Active
- FDA GUDID UDI-DI 00853954003241 listed 24 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K152539
- Listed FDA GUDID 00853954003241
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- X-Pac
- Generic name
- Metallic spinal fusion cage, non-sterile
- Model / Ref / Catalog
- SV2453
- Primary DI / UDI-DI
- 00853954003241
- 510(k) Number
- FDA product code
- MAX
- GMDN term
- Metallic spinal fusion cage, non-sterile
- 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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- Idys™- TLIF 06761011 by Clariance, Inc.