EZ-Track CAAB301114F
EZ-Track CAAB301114F is a Class II device made by Next Orthosurgical, cleared under FDA 510(k) K131082 on 26 Aug 2013 and listed in FDA GUDID since 28 Aug 2024 (UDI-DI 00840314122339), 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 | Number00840314122339 | Date28 Aug 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK131082 | Date26 Aug 2013 | StatusActive |
Official records
- AccessGUDID record 00840314122339
- FDA 510(k) database K131082
Across registries
- FDA 510(k) K131082 decided 26 Aug 2013 Active
- FDA GUDID UDI-DI 00840314122339 listed 28 Aug 2024 Listed
Timeline
- Cleared FDA 510(k) K131082
- Listed FDA GUDID 00840314122339
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- EZ-Track
- Generic name
- Polymeric spinal interbody fusion cage
- Model / Ref / Catalog
- CAAB301114F
- Primary DI / UDI-DI
- 00840314122339
- 510(k) Number
- FDA product code
- MAX
- GMDN term
- Polymeric 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
- Size
- Width — 11 MillimeterLength — 30 MillimeterHeight — 14 MillimeterAngle — 5 degree
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