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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, nondegradable, soft tissue
510(k) Number K190728
Device Name Arthrex SwiveLock Anchors
Applicant
Arthrex Inc.
1370 Creekside Boulevard
naples,  FL  34108 -1945
Applicant Contact jessica l. singelais
Correspondent
Arthrex Inc.
1370 Creekside Boulevard
naples,  FL  34108 -1945
Correspondent Contact jessica l. singelais
Regulation Number888.3040
Classification Product Code
MBI  
Date Received03/21/2019
Decision Date 04/17/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Special
Reviewed by Third Party No
Combination Product No
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