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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cerclage, Fixation
510(k) Number K231333
Device Name STRETTO™ Cable System
Applicant
Globus Medical, Inc.
2560 General Armistead Ave.
Audubon,  PA  19403
Applicant Contact Jennifer Antonacci
Correspondent
Globus Medical, Inc.
2560 General Armistead Ave.
Audubon,  PA  19403
Correspondent Contact Jennifer Antonacci
Regulation Number888.3010
Classification Product Code
JDQ  
Subsequent Product Codes
HRS   HWC  
Date Received05/08/2023
Decision Date 08/04/2023
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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