Arthrex Corkscrew And SwiveLock 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 Corkscrew And Swivelock Suture Anchors.

Pre-market Notification Details

Device IDK143745
510k NumberK143745
Device Name:Arthrex Corkscrew And SwiveLock 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 Received2014-12-31
Decision Date2015-07-02
Summary:summary

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