X-Pac EI2449L
by Expanding Innovations, Inc.
X-Pac EI2449L is a Class II device made by Expanding Innovations, Inc., cleared under FDA 510(k) K152539 on 24 Feb 2016 and listed in FDA GUDID since 23 Nov 2018 (UDI-DI 00850001720038), active as of 23 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 | Number00850001720038 | Date23 Nov 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK152539 | Date24 Feb 2016 | StatusActive |
Official records
- AccessGUDID record 00850001720038
- FDA 510(k) database K152539
Across registries
- FDA 510(k) K152539 decided 24 Feb 2016 Active
- FDA GUDID UDI-DI 00850001720038 listed 23 Nov 2018 Listed
Timeline
- Cleared FDA 510(k) K152539
- Listed FDA GUDID 00850001720038
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- X-Pac
- Generic name
- Metallic spinal interbody fusion cage
- Model / Ref / Catalog
- EI2449L
- Primary DI / UDI-DI
- 00850001720038
- FDA product code
- MAX
- GMDN term
- Metallic spinal interbody fusion cage
- Device class
- Class II
- Regulation number
- 888.3080
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Similar devices in this category
Other devices filed under Metallic spinal interbody fusion cage.
- ACDF Stand Alone Cervical 03.18.717 by Medacta International SA
- JULIET ® Ti LL JLT-M8 40 10-S by Spineart
- Catalyft PL Expandable Interbody System 6068116 by MEDTRONIC SOFAMOR DANEK, INC.
- JULIET ® Ti LL JLT-S0 60 16-S by Spineart
- Catalyft PL Expandable Interbody System 6068076 by MEDTRONIC SOFAMOR DANEK, INC.