Idys ALIF ZP 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 Alif Zp 3dti.

Pre-market Notification Details

Device IDK192168
501k NumberK192168
Device Name:Idys ALIF ZP 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, Suite 2300 Philadelphia,  PA  19103
Product CodeOVD  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
501k Review PanelOrthopedic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-09
Decision Date2019-11-04

© 2019 FDA.report
This site is not affiliated with or endorsed by the FDA.