The following data is part of a premarket notification filed by Globus Medical Inc. with the FDA for Excelsiushub.
| Device ID | K211616 |
| 510k Number | K211616 |
| Device Name: | ExcelsiusHub |
| Classification | Orthopedic Stereotaxic Instrument |
| 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 | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-26 |
| Decision Date | 2021-08-25 |