Ngage 450258-0001
Ngage 450258-0001 (74-0006) is a Class II device made by Orthofix US LLC, cleared under FDA 510(k) K032700 on 9 Oct 2003 and listed in FDA GUDID since 12 Mar 2019 (UDI-DI 18257200081691), 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 | Number18257200081691 | Date12 Mar 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK032700 | Date9 Oct 2003 | StatusActive |
Official records
- AccessGUDID record 18257200081691
- FDA 510(k) database K032700
Across registries
- FDA 510(k) K032700 decided 9 Oct 2003 Active
- FDA GUDID UDI-DI 18257200081691 listed 12 Mar 2019 Listed
Timeline
- Cleared FDA 510(k) K032700
- Listed FDA GUDID 18257200081691
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Ngage
- Generic name
- Metallic spinal interbody fusion cage
- Model / Ref / Catalog
- 450258-0001, 74-0006
- Primary DI / UDI-DI
- 18257200081691
- 510(k) Number
- FDA product code
- MQP
- GMDN term
- Metallic spinal interbody fusion cage
- Device class
- Class II
- Regulation number
- 888.3060
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization