Betta Link Knotless Implant System

Fastener, Fixation, Nondegradable, Soft Tissue

T.A.G. Medical Products Corporation, Ltd

The following data is part of a premarket notification filed by T.a.g. Medical Products Corporation, Ltd with the FDA for Betta Link Knotless Implant System.

Pre-market Notification Details

Device IDK210498
510k NumberK210498
Device Name:Betta Link Knotless Implant System
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant T.A.G. Medical Products Corporation, Ltd Gaaton Gaaton,  IL 2513000
ContactShlomi Dines
CorrespondentAnat Rozen
T.A.G. Medical Products Corporation, Ltd Gaaton Gaaton,  IL 2513000
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-22
Decision Date2021-03-24

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