The following data is part of a premarket notification filed by Materialise Nv with the FDA for Materialise Tka Guide System.
| Device ID | K173445 |
| 510k Number | K173445 |
| Device Name: | Materialise TKA Guide System |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/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 | JWH |
| Subsequent Product Code | MBH |
| Subsequent Product Code | OIY |
| Subsequent Product Code | OOG |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-06 |
| Decision Date | 2018-02-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05420060310461 | K173445 | 000 |
| 05420060310027 | K173445 | 000 |
| 05420060310034 | K173445 | 000 |
| 05420060310041 | K173445 | 000 |
| 05420060310058 | K173445 | 000 |
| 05420060310065 | K173445 | 000 |
| 05420060310119 | K173445 | 000 |
| 05420060310126 | K173445 | 000 |
| 05420060310133 | K173445 | 000 |
| 05420060310140 | K173445 | 000 |
| 05420060310430 | K173445 | 000 |
| 05420060310010 | K173445 | 000 |