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FDA 510(k)

TruMatch CMF Titanium 3D Printed Implant System

K-Number: K170272 · 2017-08-08

ApplicantMaterialise NV
Decision Date2017-08-08
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TruMatch CMF Titanium 3D Printed Implant System is a medical device manufactured by Materialise NV. It received FDA 510(k) clearance on 2017-08-08 under approval number K170272. 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 System?

TruMatch CMF Titanium 3D Printed Implant System is a medical device that received FDA 510(k) clearance on 2017-08-08. It is manufactured by Materialise NV. The 510(k) number is K170272.

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

TruMatch CMF Titanium 3D Printed Implant System received FDA 510(k) clearance on 2017-08-08, under approval number K170272.

What company makes TruMatch CMF Titanium 3D Printed Implant System?

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

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

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

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Related PubMed Literature

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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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