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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 K210498
Device Name Betta Link Knotless Implant System
Applicant
T.A.G. Medical Products Corporation, Ltd
Gaaton
Gaaton,  IL 2513000
Applicant Contact Shlomi Dines
Correspondent
T.A.G. Medical Products Corporation, Ltd
Gaaton
Gaaton,  IL 2513000
Correspondent Contact Anat Rozen
Regulation Number888.3040
Classification Product Code
MBI  
Date Received02/22/2021
Decision Date 03/24/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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