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  |