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 |