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 IDK210912
510k NumberK210912
Device Name:Excelsius3D
ClassificationInterventional Fluoroscopic X-ray System
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 CodeOWB  
Subsequent Product CodeJAA
Subsequent Product CodeOXO
CFR Regulation Number892.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-29
Decision Date2021-08-12

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00193982184537 K210912 000
00193982184506 K210912 000

Trademark Results [Excelsius3D]

Mark Image

Registration | Serial
Company
Trademark
Application Date
EXCELSIUS3D
EXCELSIUS3D
90884243 not registered Live/Pending
Globus Medical, Inc.
2021-08-16

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