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 |