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FDA 510(k)

TruMatch CMF Titanium 3D Printed Implant

K-Number: K173039 · 2018-07-10

ApplicantMaterialise NV
Decision Date2018-07-10
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TruMatch CMF Titanium 3D Printed Implant is a medical device manufactured by Materialise NV. It received FDA 510(k) clearance on 2018-07-10 under approval number K173039. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TruMatch CMF Titanium 3D Printed Implant?

TruMatch CMF Titanium 3D Printed Implant is a medical device that received FDA 510(k) clearance on 2018-07-10. It is manufactured by Materialise NV. The 510(k) number is K173039.

When was TruMatch CMF Titanium 3D Printed Implant approved by the FDA?

TruMatch CMF Titanium 3D Printed Implant received FDA 510(k) clearance on 2018-07-10, under approval number K173039.

What company makes TruMatch CMF Titanium 3D Printed Implant?

TruMatch CMF Titanium 3D Printed Implant is manufactured by Materialise NV.

What is the FDA product code for TruMatch CMF Titanium 3D Printed Implant?

The FDA product code for TruMatch CMF Titanium 3D Printed Implant is JEY.

Related Clinical Trials

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Other Devices by Materialise NV

K162273Materialise TKA Guide System K153602Materialise Glenoid Positioning System K172650Materialise PKA Guide System K172054Materialise Glenoid Positioning System K170272TruMatch CMF Titanium 3D Printed Implant System K170893Materialise Glenoid Positioning System

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Related Devices (Code: JEY)

K160363OPTIMUS CMF SYSTEMOsteonic Co., Ltd. K163579KLS Martin Individual Patient SolutionsKLS Martin L.P. K170773Stryker Universal MeshStryker K172572Stryker Upper-Face AXS screws and Mid-Face AXS screwsStryker K170272TruMatch CMF Titanium 3D Printed Implant SystemMaterialise NV K171364MP LeFort I PlatesStryker

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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