Idys LLIF 3DTi

Intervertebral Fusion Device With Integrated Fixation, Lumbar

Clariance, SAS

The following data is part of a premarket notification filed by Clariance, Sas with the FDA for Idys Llif 3dti.

Pre-market Notification Details

Device IDK202032
510k NumberK202032
Device Name:Idys LLIF 3DTi
ClassificationIntervertebral Fusion Device With Integrated Fixation, Lumbar
Applicant Clariance, SAS 18, Rue Robespierre Beaurains,  FR 62217
ContactFadwa Bahr
CorrespondentJanice M. Hogan
Hogan Lovells US LLP 1735 Market Street, 23rd Floor Philadelphia,  PA  19103
Product CodeOVD  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-22
Decision Date2021-04-01

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