Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Fastener, Fixation, Nondegradable, Soft Tissue
510(k) Number K252635
Device Name ArthroTAK Tendon Anchor Kit
Applicant
ArthroTAK, LLC
2925 Stockyard Rd., Suite B
Missoula,  MT  59808
Applicant Contact Don Running
Correspondent
RPC Consulting, LLC
15183 Harrison Lake Cove
Fort Wayne,  IN  46814
Correspondent Contact Ken Riordan
Regulation Number888.3040
Classification Product Code
MBI  
Date Received08/20/2025
Decision Date 05/01/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-