EXCELSIUS GPS
Orthopedic Stereotaxic Instrument
Globus Medical Inc.
The following data is part of a premarket notification filed by Globus Medical Inc. with the FDA for Excelsius Gps.
Pre-market Notification Details
| Device ID | K171651 |
| 510k Number | K171651 |
| Device Name: | EXCELSIUS GPS |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-05 |
| Decision Date | 2017-08-16 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889095998511 | K171651 | 000 |
| 00889095481297 | K171651 | 000 |
| 00193982520878 | K171651 | 000 |
| 00193982520861 | K171651 | 000 |
| 00889095375640 | K171651 | 000 |
| 00889095375633 | K171651 | 000 |
| 00889095375626 | K171651 | 000 |
| 00889095375619 | K171651 | 000 |
| 00889095375602 | K171651 | 000 |
| 00889095375589 | K171651 | 000 |
| 00193982263218 | K171651 | 000 |
| 00193982263225 | K171651 | 000 |
| 00193982263232 | K171651 | 000 |
| 00889095998504 | K171651 | 000 |
| 00889095998498 | K171651 | 000 |
| 00889095998481 | K171651 | 000 |
| 00889095995176 | K171651 | 000 |
| 00889095995169 | K171651 | 000 |
| 00889095375596 | K171651 | 000 |
| 00193982278724 | K171651 | 000 |
| 00193982278717 | K171651 | 000 |
| 00193982278731 | K171651 | 000 |
| 00193982637354 | K171651 | 000 |
Trademark Results [EXCELSIUS GPS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EXCELSIUS GPS 87074053 5365778 Live/Registered |
Globus Medical Inc. 2016-06-16 |
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