DIP Arthrodesis System

Pin, Fixation, Smooth

In2Bones SAS

The following data is part of a premarket notification filed by In2bones Sas with the FDA for Dip Arthrodesis System.

Pre-market Notification Details

Device IDK173616
510k NumberK173616
Device Name:DIP Arthrodesis System
ClassificationPin, Fixation, Smooth
Applicant In2Bones SAS 28 Chemin Du Petit Bois Ecully,  FR 69130
ContactMorgane Grenier
CorrespondentChristine Scifert
MRC-X, LLC 6075 Poplar Avenue Suite 500 Memphis,  TN  38119
Product CodeHTY  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-11-22
Decision Date2018-01-19
Summary:summary

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