Idys ALIF ZP 3DTi

Intervertebral Fusion Device With Bone Graft, Lumbar

Clariance, SAS

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

Pre-market Notification Details

Device IDK200920
510k NumberK200920
Device Name:Idys ALIF ZP 3DTi
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant Clariance, SAS 18 Rue Robespierre Beaurains,  FR 62217
ContactFadwa Bahr
CorrespondentJanice M. Hogan
Hogan Lovells US LLP 1735 Market Street, Suite 2300 Philadelphia,  PA  19103
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-06
Decision Date2020-05-29

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