Arthrex Mini Comprehensive Fixation System - 1.0mm Screws

Screw, 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 - 1.0mm Screws.

Pre-market Notification Details

Device IDK193156
510k NumberK193156
Device Name:Arthrex Mini Comprehensive Fixation System - 1.0mm Screws
ClassificationScrew, Fixation, Bone
Applicant Arthrex Inc. 1370 Creekside Boulevard Naples,  FL  34108 -1945
ContactRebecca R. Homan
CorrespondentRebecca R. Homan
Arthrex Inc. 1370 Creekside Boulevard Naples,  FL  34108 -1945
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-14
Decision Date2020-02-10

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