The following data is part of a premarket notification filed by Materialise Nv with the FDA for Materialise Pka Guide System.
| Device ID | K172650 |
| 510k Number | K172650 |
| Device Name: | Materialise PKA Guide System |
| Classification | Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer |
| Applicant | Materialise NV Technologielaan 15 Leuven, BE 3001 |
| Contact | Oliver Clemens |
| Correspondent | Oliver Clemens Materialise NV Technologielaan 15 Leuven, BE 3001 |
| Product Code | HSX |
| CFR Regulation Number | 888.3520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-05 |
| Decision Date | 2017-11-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556700204 | K172650 | 000 |
| 00885556700167 | K172650 | 000 |