Autobahn 1183.0028
Autobahn 1183.0028 is a Class II device made by Globus Medical, Inc., cleared under FDA 510(k) K171108 on 29 Dec 2017 and listed in FDA GUDID since 28 Jun 2019 (UDI-DI 00889095469240), 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 | Number00889095469240 | Date28 Jun 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK171108 | Date29 Dec 2017 | StatusActive |
Official records
- AccessGUDID record 00889095469240
- FDA 510(k) database K171108
Across registries
- FDA 510(k) K171108 decided 29 Dec 2017 Active
- FDA GUDID UDI-DI 00889095469240 listed 28 Jun 2019 Listed
Timeline
- Cleared FDA 510(k) K171108
- Listed FDA GUDID 00889095469240
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Autobahn
- Generic name
- Arthrodesis intramedullary nail, non-distracting
- Model / reference
- 1183.0028
- Primary DI / UDI-DI
- 00889095469240
- 510(k) Number
- FDA product code
- HSB, JDS, HWC
- GMDN term
- Arthrodesis intramedullary nail, non-distracting
- Device class
- Class II
- Regulation number
- 888.3020, 888.3030, 888.3040
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
- Size
- Length — 27.5 MillimeterOuter Diameter — 4 Millimeter