Y-Knot OneStep Anchor

Fastener, Fixation, Nondegradable, Soft Tissue

ConMed Corporation

The following data is part of a premarket notification filed by Conmed Corporation with the FDA for Y-knot Onestep Anchor.

Pre-market Notification Details

Device IDK193606
510k NumberK193606
Device Name:Y-Knot OneStep Anchor
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant ConMed Corporation 525 French Road Utica,  NY  13502
ContactCarrie Engleman
CorrespondentCarrie Engleman
ConMed Corporation 525 French Road Utica,  NY  13502
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
510k Review PanelOrthopedic
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-23
Decision Date2020-01-22

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