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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 K252596
Device Name Tigon Medical Knotless and Dual Javelin All-Suture Anchors
Applicant
Tigon Medical
303 Najoles Rd., Suite 104
Millersville,  MD  21108
Applicant Contact Jeremy Clark
Correspondent
Tigon Medical
303 Najoles Rd., Suite 104
Millersville,  MD  21108
Correspondent Contact Jeremy Clark
Regulation Number888.3040
Classification Product Code
MBI  
Date Received08/15/2025
Decision Date 12/04/2025
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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