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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthopedic Stereotaxic Instrument
510(k) Number K250599
Device Name ExcelsiusGPS™ Instruments
Applicant
Globus Medical, Inc.
Valley Forge Business Center
2560 General Armistead Ave.
Audubon,  CA  19403
Applicant Contact Jennifer Antonacci
Correspondent
Globus Medical, Inc.
Valley Forge Business Center
2560 General Armistead Ave.
Audubon,  CA  19403
Correspondent Contact Jennifer Antonacci
Regulation Number882.4560
Classification Product Code
OLO  
Subsequent Product Codes
MAX   ODP   OVD  
Date Received02/28/2025
Decision Date 11/05/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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