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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 K200341
Device Name Arthrex FiberTak Suture Anchor
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 Received02/11/2020
Decision Date 03/12/2020
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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