Ingenix 5057545
Ingenix 5057545 is a Class II device made by Ingenium Spine, cleared under FDA 510(k) K241258 on 4 Jun 2024 and listed in FDA GUDID since 24 Feb 2025 (UDI-DI 00843672101817), 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 | Number00843672101817 | Date24 Feb 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK241258 | Date4 Jun 2024 | StatusActive |
Official records
- AccessGUDID record 00843672101817
- FDA 510(k) database K241258
Across registries
- FDA 510(k) K241258 decided 4 Jun 2024 Active
- FDA GUDID UDI-DI 00843672101817 listed 24 Feb 2025 Listed
Timeline
- Cleared FDA 510(k) K241258
- Listed FDA GUDID 00843672101817
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Ingenix
- Generic name
- Spinal bone screw, non-bioabsorbable
- Model / reference
- 5057545
- Primary DI / UDI-DI
- 00843672101817
- 510(k) Number
- FDA product code
- NKB
- GMDN term
- Spinal bone screw, non-bioabsorbable
- Device class
- Class II
- Regulation number
- 888.3070
- GUDID distribution status
- In Commercial Distribution
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