Arthrex NanoSuture 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 Nanosuture Anchor.

Pre-market Notification Details

Device IDK180118
510k NumberK180118
Device Name:Arthrex NanoSuture Anchor
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant Arthrex Inc. 1370 Creekside Boulevard Naples,  FL  34108 -5553
ContactRebecca R. Homan
CorrespondentRebecca R. Homan
Arthrex Inc. 1370 Creekside Boulevard Naples,  FL  34108 -5553
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-01-16
Decision Date2018-02-12
Summary:summary

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