The following data is part of a premarket notification filed by Globus Medical Inc. with the FDA for Si-lok® Sacroiliac Joint Fixation System, Navigation Instruments, Excelsiusgps® Instruments.
| Device ID | K183119 |
| 510k Number | K183119 |
| Device Name: | SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS® Instruments |
| Classification | Sacroiliac Joint Fixation |
| Applicant | Globus Medical Inc. Valley Forge Business Center 2560 General Armistead Ave. Audubon, PA 19403 |
| Contact | Lori Burns |
| Correspondent | Lori Burns Globus Medical Inc. Valley Forge Business Center 2560 General Armistead Ave. Audubon, PA 19403 |
| Product Code | OUR |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-09 |
| Decision Date | 2019-02-06 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SI-LOK 85264204 4176597 Live/Registered |
Globus Medical Inc. 2011-03-11 |