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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 K262809
Device Name ArthroTAK Tendon Anchor Kit
Applicant
ArthroTAK, LLC
2925 Stockyard Rd., Suite B
Missoula,  MT  59808
Applicant Contact Don Running
Correspondent
Greenfield Consulting, LLC
1709 Crestwood Rd.
West Bend,  WI  53095
Correspondent Contact Ken Riordan
Regulation Number888.3040
Classification Product Code
MBI  
Date Received08/07/2026
Decision Date 09/02/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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