The following data is part of a premarket notification filed by Globus Medical Inc. with the FDA for Corridor Fixation System.
| Device ID | K192744 |
| 510k Number | K192744 |
| Device Name: | CORRIDOR Fixation System |
| Classification | System, Facet Screw Spinal Device |
| 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 | MRW |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-30 |
| Decision Date | 2019-12-16 |