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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interventional Fluoroscopic X-Ray System
510(k) Number K210912
Device Name Excelsius3D
Applicant
Globus Medical Inc.
2560 General Armistead Ave.
Audubon,  PA  19403
Applicant Contact Kelly Baker
Correspondent
Globus Medical Inc.
2560 General Armistead Ave.
Audubon,  PA  19403
Correspondent Contact Kelly Baker
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Codes
JAA   OXO  
Date Received03/29/2021
Decision Date 08/12/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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