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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 the device name listed in this FDA 510(k) record. The listed applicant is Materialise NV. It received FDA 510(k) clearance on 2018-07-10 under 510(k) 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. The listed applicant is Materialise NV. The 510(k) number is K173039.

When did TruMatch CMF Titanium 3D Printed Implant receive FDA 510(k) clearance?

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

Who is the listed applicant for TruMatch CMF Titanium 3D Printed Implant?

The FDA 510(k) record lists Materialise NV as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Materialise NV as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260802Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder PlannerK251964Mimics Thoracic PlannerK253308Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic ModelsK253793Materialise TKA Guide SystemK251554Materialise TKA Guide SystemK243637Materialise Personalized Guides and Models for Craniomaxillofacial Surgery

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Related Devices (Code: JEY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253206METICULY Patient-specific CMF solutionMeticuly Co., Ltd.K252246Leforte MMF SystemJeil Medical CorporationK253373Southern Craniomaxillofacial (CMF) SystemSouthern Medical (Pty) , Ltd.K251441Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation SystemInion OYK241314KLS Martin Oral-Max Implants MR Conditional (bundled)KLS-Martin L.P.K240651MRI UniversalStryker Leibinger GmbH & Co KG

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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