The following data is part of a premarket notification filed by Materialise Nv with the FDA for Trumatch Cmf Titanium 3d Printed Implant.
| Device ID | K173039 |
| 510k Number | K173039 |
| Device Name: | TruMatch CMF Titanium 3D Printed Implant |
| Classification | Plate, Bone |
| Applicant | Materialise NV Technologielaan 15 Leuven, BE 3001 |
| Contact | Lina Ramirez |
| Correspondent | Lina Ramirez Materialise NV Technologielaan 15 Leuven, BE 3001 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-28 |
| Decision Date | 2018-07-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05420060381096 | K173039 | 000 |
| 05420060381089 | K173039 | 000 |
| 05420060381072 | K173039 | 000 |
| 05420060381065 | K173039 | 000 |
| 05420060381058 | K173039 | 000 |