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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 K221099
Device Name Arthrex Self-Punching PushLock Suture Anchor
Applicant
Arthrex, Inc.
1370 Creekside Blvd.
Naples,  FL  34108 -1945
Applicant Contact Kelsey Roberts
Correspondent
Arthrex, Inc.
1370 Creekside Blvd.
Naples,  FL  34108 -1945
Correspondent Contact Kelsey Roberts
Regulation Number888.3030
Classification Product Code
MAI  
Subsequent Product Codes
HWC   MBI  
Date Received04/14/2022
Decision Date 05/13/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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