UNiD IB3D ALIF

Intervertebral Fusion Device With Bone Graft, Lumbar

Medicrea International S.A.

The following data is part of a premarket notification filed by Medicrea International S.a. with the FDA for Unid Ib3d Alif.

Pre-market Notification Details

Device IDK200316
510k NumberK200316
Device Name:UNiD IB3D ALIF
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant Medicrea International S.A. 5389, Route De Strasbourg Rillieux-la-pape,  FR 69140
ContactDavid Ryan
CorrespondentDavid Ryan
Medicrea International S.A. 5389, Route De Strasbourg Rillieux-la-pape,  FR 69140
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-07
Decision Date2020-10-30

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