Elsa 1122.2065
Elsa 1122.2065 is a Class II device made by Globus Medical, Inc., cleared under FDA 510(k) K161379 on 29 Sep 2016 and listed in FDA GUDID since 24 Jan 2021 (UDI-DI 00889095334524), 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 | Number00889095334524 | Date24 Jan 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK161379 | Date29 Sep 2016 | StatusActive |
Official records
- AccessGUDID record 00889095334524
- FDA 510(k) database K161379
Across registries
- FDA 510(k) K161379 decided 29 Sep 2016 Active
- FDA GUDID UDI-DI 00889095334524 listed 24 Jan 2021 Listed
Timeline
- Cleared FDA 510(k) K161379
- Listed FDA GUDID 00889095334524
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Elsa
- Generic name
- Metallic spinal interbody fusion cage
- Model / reference
- 1122.2065
- Primary DI / UDI-DI
- 00889095334524
- 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
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