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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Washer, Bolt Nut
510(k) Number K240947
Device Name TENSOR® Suture Button System
Applicant
Globus Medical, Inc
Valley Forge Business Center
2560 General Armistead Ave
Audubon,  PA  19403
Applicant Contact Jennifer Antonacci
Correspondent
Globus Medical, Inc
Valley Forge Business Center
2560 General Armistead Ave
Audubon,  PA  19403
Correspondent Contact Jennifer Antonacci
Regulation Number888.3030
Classification Product Code
HTN  
Subsequent Product Code
MBI  
Date Received04/08/2024
Decision Date 06/03/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
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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