Arthrex FiberTak Suture Anchor

Fastener, Fixation, Nondegradable, Soft Tissue

Arthrex Inc.

The following data is part of a premarket notification filed by Arthrex Inc. with the FDA for Arthrex Fibertak Suture Anchor.

Pre-market Notification Details

Device IDK200341
510k NumberK200341
Device Name:Arthrex FiberTak Suture Anchor
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant Arthrex Inc. 1370 Creekside Boulevard Naples,,  FL  34108 -1945
ContactJessica L. Singelais
CorrespondentJessica L. Singelais
Arthrex Inc. 1370 Creekside Boulevard Naples,,  FL  34108 -1945
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
510k Review PanelOrthopedic
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-11
Decision Date2020-03-12

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