X-Pac SV2458
X-Pac SV2458 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 00853954003289), 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 | Number00853954003289 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK152539 | Date24 Feb 2016 | StatusActive |
Official records
- AccessGUDID record 00853954003289
- FDA 510(k) database K152539
Across registries
- FDA 510(k) K152539 decided 24 Feb 2016 Active
- FDA GUDID UDI-DI 00853954003289 listed 24 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K152539
- Listed FDA GUDID 00853954003289
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- Withdrawn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
- SV2458
- Primary DI / UDI-DI
- 00853954003289
- 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
Similar devices
Other devices filed under FDA product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar).
- COROENT SYSTEM by Nu Vasive, Incorporated
- BIOMET LATERAL SPACER SYSTEM by Biomet Spine (Aka Ebi, LLC)
- AVS PL PEEK SPACERS, MODELS 48351XXX AND 48353XXX by Stryker Spine
- JULIET ® Ti LL JLT-MY 50 16-S by Spineart
- MOBIS II ST SPINAL IMPLANT by SIGNUS Medizintechnik GmbH
- CONCORDE 187827109 by MEDOS INTERNATIONAL SARL
- CONCORDE 196927213 by MEDOS INTERNATIONAL SARL
- TranS1 Interbody Fusion System by Trans1
- Idys®-ALIF ZP 3DTI 45571210-S by Clariance, Inc.
- Lumbar Interbody Fusion System (OLLIF) by ADVANCED RESEARCH MEDICAL LLC