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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 K171141
Device Name Arthrex SwiveLock Anchors
Applicant
Arthrex Inc.
1370 Creekside Boulevard
Naples,  FL  71924
Applicant Contact David L. Rogers
Correspondent
Arthrex Inc.
1370 Creekside Boulevard
Naples,  FL  34108
Correspondent Contact David L. Rogers
Regulation Number888.3030
Classification Product Code
MAI  
Subsequent Product Code
MBI  
Date Received04/18/2017
Decision Date 05/04/2017
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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