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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Staple, Fixation, Bone
510(k) Number K243742
Device Name Arthrex DynaNite Nitinol Staples
Applicant
Arthrex Inc.
1370 Creekside Blvd.
Naples,  FL  34108
Applicant Contact Kelsey Roberts
Correspondent
Arthrex Inc.
1370 Creekside Blvd.
Naples,  FL  34108
Correspondent Contact Rebecca R Homan
Regulation Number888.3030
Classification Product Code
JDR  
Subsequent Product Code
JDQ  
Date Received12/04/2024
Decision Date 01/31/2025
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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