Arthrex Mini Comprehensive Fixation System – 2.0mm & 2.4mm Module

Plate, Fixation, Bone

Arthrex Inc.

The following data is part of a premarket notification filed by Arthrex Inc. with the FDA for Arthrex Mini Comprehensive Fixation System – 2.0mm & 2.4mm Module.

Pre-market Notification Details

Device IDK191344
510k NumberK191344
Device Name:Arthrex Mini Comprehensive Fixation System – 2.0mm & 2.4mm Module
ClassificationPlate, Fixation, Bone
Applicant Arthrex Inc. 1370 Creekside Boulevard Naples,  FL  34108 -1945
ContactRebecca R. Homan R. Homan
CorrespondentRebecca R. Homan
Arthrex Inc. 1370 Creekside Boulevard Naples,  FL  34108 -1945
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-05-20
Decision Date2019-10-03

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