ExcelsiusHub

Orthopedic Stereotaxic Instrument

Globus Medical Inc.

The following data is part of a premarket notification filed by Globus Medical Inc. with the FDA for Excelsiushub.

Pre-market Notification Details

Device IDK211616
510k NumberK211616
Device Name:ExcelsiusHub
ClassificationOrthopedic Stereotaxic Instrument
Applicant Globus Medical Inc. 2560 General Armistead Ave. Audubon,  PA  19403
ContactKelly Baker
CorrespondentKelly Baker
Globus Medical Inc. 2560 General Armistead Ave. Audubon,  PA  19403
Product CodeOLO  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-26
Decision Date2021-08-25

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.