UNiD Patient Specific 3D Printed Cage

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 Patient Specific 3d Printed Cage.

Pre-market Notification Details

Device IDK173782
510k NumberK173782
Device Name:UNiD Patient Specific 3D Printed Cage
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant Medicrea International S.A. 5389 Route De Strasbourg-Vancia Rillieux-la-pape,  FR 69140
ContactDavid Ryan
CorrespondentDavid Ryan
Medicrea International S.A. 5389 Route De Strasbourg-Vancia Rillieux-la-pape,  FR 69140
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-12-13
Decision Date2018-04-25

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