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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
510(k) Number K232897
Device Name Arthrex Small External Fixation System
Applicant
Arthrex Inc
1370 Creekside Boulevard
Naples,  FL  34108 -1945
Applicant Contact Jessica Kim
Correspondent
Arthrex Inc
1370 Creekside Boulevard
Naples,  FL  34108 -1945
Correspondent Contact Jessica Kim
Regulation Number888.3030
Classification Product Code
KTT  
Subsequent Product Code
JDW  
Date Received09/18/2023
Decision Date 10/18/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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