Fortify 151.334S
Fortify 151.334S is a Class II device made by Globus Medical, Inc., cleared under FDA 510(k) K162315 on 9 Nov 2017 and listed in FDA GUDID since 15 Sep 2022 (UDI-DI 00889095616750), 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 | Number00889095616750 | Date15 Sep 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK162315 | Date9 Nov 2017 | StatusActive |
Official records
- AccessGUDID record 00889095616750
- FDA 510(k) database K162315
Across registries
- FDA 510(k) K162315 decided 9 Nov 2017 Active
- FDA GUDID UDI-DI 00889095616750 listed 15 Sep 2022 Listed
Timeline
- Cleared FDA 510(k) K162315
- Listed FDA GUDID 00889095616750
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Fortify
- Generic name
- Vertebral body prosthesis
- Model / reference
- 151.334S
- Primary DI / UDI-DI
- 00889095616750
- 510(k) Number
- FDA product code
- MQP, PLR
- GMDN term
- Vertebral body prosthesis
- Device class
- Class II
- Regulation number
- 888.3060
- GUDID distribution status
- In Commercial Distribution
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