Arbor 2173.8604
Arbor 2173.8604 is a Class II device made by Globus Medical, Inc., cleared under FDA 510(k) K172438 on 12 Jan 2018 and listed in FDA GUDID since 12 Jul 2019 (UDI-DI 00889095534948), 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 | Number00889095534948 | Date12 Jul 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK172438 | Date12 Jan 2018 | StatusActive |
Official records
- AccessGUDID record 00889095534948
- FDA 510(k) database K172438
Across registries
- FDA 510(k) K172438 decided 12 Jan 2018 Active
- FDA GUDID UDI-DI 00889095534948 listed 12 Jul 2019 Listed
Timeline
- Cleared FDA 510(k) K172438
- Listed FDA GUDID 00889095534948
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Arbor
- Generic name
- External orthopaedic fixation system, single-use
- Model / reference
- 2173.8604
- Primary DI / UDI-DI
- 00889095534948
- 510(k) Number
- FDA product code
- KTT, LXT
- GMDN term
- External orthopaedic fixation system, single-use
- Device class
- Class II
- Regulation number
- 888.3030
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Similar devices in this category
Other devices filed under External orthopaedic fixation system, single-use.