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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 K230433
Device Name Arthrex Knotless FiberTak Suture Anchor
Applicant
Arthrex Inc.
1370 Creekside Blvd
Naples,  FL  34108
Applicant Contact Kelsey Roberts
Correspondent
Arthrex Inc.
1370 Creekside Blvd
Naples,  FL  34108
Correspondent Contact Kelsey Roberts
Regulation Number888.3040
Classification Product Code
MBI  
Date Received02/17/2023
Decision Date 03/10/2023
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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