OS2-C Compression Staple

Staple, Fixation, Bone

IN2BONES SAS

The following data is part of a premarket notification filed by In2bones Sas with the FDA for Os2-c Compression Staple.

Pre-market Notification Details

Device IDK153395
510k NumberK153395
Device Name:OS2-C Compression Staple
ClassificationStaple, Fixation, Bone
Applicant IN2BONES SAS 28 CHEMIN DU PETIT BOIS Ecully,  FR 63130
ContactMorgane Grenier
CorrespondentNorman F Estrin
ESTRIN CONSULTING GROUP LLC 9109 COPENHAVER DRIVE Potomac,  MD  20854
Product CodeJDR  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-11-24
Decision Date2016-02-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03760225711163 K153395 000
03760225711156 K153395 000
03760225711149 K153395 000

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