The following data is part of a premarket notification filed by Globus Medical Inc. with the FDA for Autobahn Nailing System.
| Device ID | K171108 | 
| 510k Number | K171108 | 
| Device Name: | AUTOBAHN Nailing System | 
| Classification | Rod, Fixation, Intramedullary And Accessories | 
| Applicant | Globus Medical Inc. 2560 General Armistead Ave. Audubon, PA 19403 | 
| Contact | Kelly J. Baker | 
| Correspondent | Kelly J. Baker Globus Medical Inc. 2560 General Armistead Ave. Audubon, PA 19403  | 
| Product Code | HSB | 
| Subsequent Product Code | HWC | 
| Subsequent Product Code | JDS | 
| CFR Regulation Number | 888.3020 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 2017-04-14 | 
| Decision Date | 2017-12-29 | 
| Summary: | summary |