TruMatch CMF Titanium 3D Printed Implant
FDA 510(k) K173039 · Materialise NV
510(k) numberK173039
Submission
- Device name
- TruMatch CMF Titanium 3D Printed Implant
- Applicant
- Materialise NV
Leuven, BE - Received
- September 28, 2017
- Decision date
- July 10, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was TruMatch CMF Titanium 3D Printed Implant cleared by the FDA?
TruMatch CMF Titanium 3D Printed Implant (K173039) received a 510(k) decision of Substantially Equivalent on July 10, 2018, 285 days after the submission was received.
What is the product code of K173039?
The FDA product code is JEY – Plate, Bone, a Class II (moderate risk) device regulated under 21 CFR 872.4760.