Excelsius3D
Interventional Fluoroscopic X-ray System
Globus Medical Inc.
The following data is part of a premarket notification filed by Globus Medical Inc. with the FDA for Excelsius3d.
Pre-market Notification Details
| Device ID | K210912 |
| 510k Number | K210912 |
| Device Name: | Excelsius3D |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | Globus Medical Inc. 2560 General Armistead Ave. Audubon, PA 19403 |
| Contact | Kelly Baker |
| Correspondent | Kelly Baker Globus Medical Inc. 2560 General Armistead Ave. Audubon, PA 19403 |
| Product Code | OWB |
| Subsequent Product Code | JAA |
| Subsequent Product Code | OXO |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-29 |
| Decision Date | 2021-08-12 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00193982184537 | K210912 | 000 |
| 00193982184506 | K210912 | 000 |
Trademark Results [Excelsius3D]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EXCELSIUS3D 90884243 not registered Live/Pending |
Globus Medical, Inc. 2021-08-16 |
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