TruMatch CMF Titanium 3D Printed Implant

Plate, Bone

Materialise NV

The following data is part of a premarket notification filed by Materialise Nv with the FDA for Trumatch Cmf Titanium 3d Printed Implant.

Pre-market Notification Details

Device IDK173039
510k NumberK173039
Device Name:TruMatch CMF Titanium 3D Printed Implant
ClassificationPlate, Bone
Applicant Materialise NV Technologielaan 15 Leuven,  BE 3001
ContactLina Ramirez
CorrespondentLina Ramirez
Materialise NV Technologielaan 15 Leuven,  BE 3001
Product CodeJEY  
CFR Regulation Number872.4760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-09-28
Decision Date2018-07-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05420060381096 K173039 000
05420060381089 K173039 000
05420060381072 K173039 000
05420060381065 K173039 000
05420060381058 K173039 000

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