The following data is part of a premarket notification filed by Materialise Nv with the FDA for Trumatch Cmf Titanium 3d Printed Implant System.
| Device ID | K170272 |
| 510k Number | K170272 |
| Device Name: | TruMatch CMF Titanium 3D Printed Implant System |
| 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 | 2017-01-30 |
| Decision Date | 2017-08-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05420060381119 | K170272 | 000 |
| 05420060380105 | K170272 | 000 |
| 05420060380099 | K170272 | 000 |
| 05420060380082 | K170272 | 000 |
| 05420060380075 | K170272 | 000 |
| 05420060380068 | K170272 | 000 |
| 05420060380051 | K170272 | 000 |
| 05420060380044 | K170272 | 000 |
| 05420060380037 | K170272 | 000 |
| 05420060380020 | K170272 | 000 |
| 05420060380013 | K170272 | 000 |
| 05420060381041 | K170272 | 000 |
| 05420060380112 | K170272 | 000 |
| 05420060380129 | K170272 | 000 |
| 05420060380136 | K170272 | 000 |
| 05420060381102 | K170272 | 000 |
| 05420060381034 | K170272 | 000 |
| 05420060381027 | K170272 | 000 |
| 05420060380211 | K170272 | 000 |
| 05420060380204 | K170272 | 000 |
| 05420060380198 | K170272 | 000 |
| 05420060380181 | K170272 | 000 |
| 05420060380174 | K170272 | 000 |
| 05420060380167 | K170272 | 000 |
| 05420060380150 | K170272 | 000 |
| 05420060380143 | K170272 | 000 |
| 05420060381133 | K170272 | 000 |