The following data is part of a premarket notification filed by Globus Medical Inc. with the FDA for Fortify Corpectomy Spacers.
| Device ID | K173982 |
| 510k Number | K173982 |
| Device Name: | FORTIFY Corpectomy Spacers |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | Globus Medical Inc. 2560 General Armistead Ave. Audubon, PA 19403 |
| Contact | Lori Burns |
| Correspondent | Lori Burns Globus Medical Inc. 2560 General Armistead Ave. Audubon, PA 19403 |
| Product Code | MQP |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-29 |
| Decision Date | 2018-09-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889095639568 | K173982 | 000 |
| 00889095639551 | K173982 | 000 |
| 00889095639544 | K173982 | 000 |
| 00889095610291 | K173982 | 000 |
| 00889095609752 | K173982 | 000 |
| 00889095609745 | K173982 | 000 |
| 00889095609585 | K173982 | 000 |