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
510k 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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-09
Decision Date2019-11-04

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03700780630486 K192168 000
03700780630332 K192168 000
03700780630325 K192168 000
03700780630318 K192168 000
03700780630301 K192168 000
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03700780630288 K192168 000
03700780630271 K192168 000
03700780630264 K192168 000
03700780630257 K192168 000
03700780630240 K192168 000
03700780630233 K192168 000
03700780630226 K192168 000
03700780630349 K192168 000
03700780630356 K192168 000
03700780630479 K192168 000
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03700780630455 K192168 000
03700780630448 K192168 000
03700780630431 K192168 000
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03700780630400 K192168 000
03700780630394 K192168 000
03700780630387 K192168 000
03700780630370 K192168 000
03700780630363 K192168 000
03700780630783 K192168 000

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