The following data is part of a premarket notification filed by Globus Medical Inc. with the FDA for Excelsiusgps.
| Device ID | K190653 |
| 510k Number | K190653 |
| Device Name: | ExcelsiusGPS |
| Classification | Orthopedic Stereotaxic Instrument |
| 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 | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-14 |
| Decision Date | 2019-04-09 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() EXCELSIUSGPS 90154135 not registered Live/Pending |
Globus Medical Inc. 2020-09-02 |
![]() EXCELSIUSGPS 87386429 5444748 Live/Registered |
Globus Medical, Inc. 2017-03-27 |