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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name fastener, fixation, biodegradable, soft tissue
510(k) Number K222263
Device Name Arthrex Self Punching SwiveLock Suture Anchors
Applicant
Arthrex Inc.
1370 Creekside Boulevard
Naples,  FL  34108
Applicant Contact Tiffany Mentzel
Correspondent
Arthrex Inc.
1370 Creekside Boulevard
Naples,  FL  34108 -1945
Correspondent Contact Tiffany Mentzel
Regulation Number888.3030
Classification Product Code
MAI  
Subsequent Product Code
MBI  
Date Received07/28/2022
Decision Date 08/26/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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