The following data is part of a premarket notification filed by Materialise Nv with the FDA for Materialise Tka Guide System.
| Device ID | K221337 |
| 510k Number | K221337 |
| 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 | Jenny Jones |
| Correspondent | Jenny Jones 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 | 2022-05-09 |
| Decision Date | 2022-07-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05420060360015 | K221337 | 000 |