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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 K232973
Device Name Arthrex Knee FiberTak® Button Suture Anchor
Applicant
Arthrex Inc
1370 Creekside Boulevard
Naples,  FL  34108 -1945
Applicant Contact Kristi Frisch
Correspondent
Arthrex Inc
1370 Creekside Boulevard
Naples,  FL  34108 -1945
Correspondent Contact Kristi Frisch
Regulation Number888.3040
Classification Product Code
MBI  
Date Received09/21/2023
Decision Date 11/15/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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