Arthrex Short Suture Anchors

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 Short Suture Anchors.

Pre-market Notification Details

Device IDK151092
510k NumberK151092
Device Name:Arthrex Short Suture Anchors
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant Arthrex, Inc. 1370 Creekside Boulevard Naples,  FL  34108 -1945
ContactDavid L Rogers
CorrespondentDavid L Rogers
Arthrex, Inc. 1370 Creekside Boulevard Naples,  FL  34108 -1945
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-04-23
Decision Date2016-02-23
Summary:summary

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