Cortical Fixation Systems

Fastener, Fixation, Nondegradable, Soft Tissue

Cousin Biotech S.A.S.

The following data is part of a premarket notification filed by Cousin Biotech S.a.s. with the FDA for Cortical Fixation Systems.

Pre-market Notification Details

Device IDK181086
510k NumberK181086
Device Name:Cortical Fixation Systems
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant Cousin Biotech S.A.S. 8 Rue De L'abbe Bonpain Wervicq-sud,  FR 59117
ContactMathilde Collet
CorrespondentFranck Pelletier
Cousin Biotech S.A.S. 8 Rue De L'abbe Bonpain Wervicq-sud,  FR 59117
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-04-25
Decision Date2019-01-09
Summary:summary

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