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 K251530
Device Name CONMED Argo Knotless® Anchor
Applicant
Conmed Corporation
525 French Rd.
Utica,  NY  13502
Applicant Contact Mirela Gjini
Correspondent
Conmed Corporation
525 French Rd.
Utica,  NY  13502
Correspondent Contact Mirela Gjini
Regulation Number888.3040
Classification Product Code
MBI  
Subsequent Product Code
MAI  
Date Received05/19/2025
Decision Date 06/18/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-