FiberStitch Implant, Curved With Two Polyester Implants And 2-0 FiberWire, FiberStitch Implant, Straight With Two Polyester Implants And 2-0 FiberWire

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 Fiberstitch Implant, Curved With Two Polyester Implants And 2-0 Fiberwire, Fiberstitch Implant, Straight With Two Polyester Implants And 2-0 Fiberwire.

Pre-market Notification Details

Device IDK221731
510k NumberK221731
Device Name:FiberStitch Implant, Curved With Two Polyester Implants And 2-0 FiberWire, FiberStitch Implant, Straight With Two Polyester Implants And 2-0 FiberWire
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant T.A.G. Medical Products Corporation, Ltd Gaaton,  IL 2513000
ContactShlomi Dines
CorrespondentShlomi Dines
T.A.G. Medical Products Corporation, Ltd Gaaton,  IL 2513000
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-06-15
Decision Date2022-09-07

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