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 |