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 |