ProAM ALIF System LN-034229-1214
ProAM ALIF System LN-034229-1214 is a Class II device made by Pro Surgical, Inc., cleared under FDA 510(k) K240126 on 3 May 2024 and listed in FDA GUDID since 16 Jan 2025 (UDI-DI 00810152900680), 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 | Number00810152900680 | Date16 Jan 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK240126 | Date3 May 2024 | StatusActive |
Official records
- AccessGUDID record 00810152900680
- FDA 510(k) database K240126
Across registries
- FDA 510(k) K240126 decided 3 May 2024 Active
- FDA GUDID UDI-DI 00810152900680 listed 16 Jan 2025 Listed
Timeline
- Cleared FDA 510(k) K240126
- Listed FDA GUDID 00810152900680
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- ProAM ALIF System
- Generic name
- Metallic spinal interbody fusion cage
- Model / Ref / Catalog
- LN-034229-1214
- Primary DI / UDI-DI
- 00810152900680
- 510(k) Number
- FDA product code
- OVD, 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