Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K243637
Materialise Personalized Guides and Models for Craniomaxillofacial Surgery · Materialise NV · decided 2025-02-21 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| TruMatch | SD980.017 | Materialise NV | JEY | 05420060380174 |
| TRUMATCH | SD980.028 | Materialise NV | DZJ LLZ | 05420060380747 |
| TRUMATCH | SD980.038 | Materialise NV | DZJ LLZ | 05420060380884 |
| TRUMATCH | SD980.035 | Materialise NV | DZJ LLZ | 05420060380853 |
| TRUMATCH | SD980.036 | Materialise NV | DZJ LLZ | 05420060380860 |
| TRUMATCH | SD980.037 | Materialise NV | DZJ LLZ | 05420060380877 |
| TRUMATCH | SD980.032 | Materialise NV | DZJ LLZ | 05420060380761 |
| TRUMATCH | SD980.034 | Materialise NV | DZJ LLZ | 05420060380846 |
| TruMatch | SD980.104 | Materialise NV | JEY | 05420060381041 |
| TruMatch | SD980.015 | Materialise NV | JEY | 05420060380150 |
| TRUMATCH | SD980.033 | Materialise NV | DZJ LLZ | 05420060380839 |
| TRUMATCH | SD980.039 | Materialise NV | DZJ LLZ | 05420060380891 |
| TRUMATCH | SD980.040 | Materialise NV | DZJ LLZ | 05420060380907 |
| TRUMATCH | SD980.031 | Materialise NV | DZJ LLZ | 05420060380754 |