The following data is part of a premarket notification filed by Materialise Nv with the FDA for Materialise Tka Guide System.
| Device ID | K162273 |
| 510k Number | K162273 |
| 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 | 2016-08-12 |
| Decision Date | 2016-11-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E314KNMLM0104010 | K162273 | 000 |
| E314KNMLM0101010 | K162273 | 000 |
| E314KNMLM010201 | K162273 | 000 |
| E314KNMLM0102010 | K162273 | 000 |
| E314KNMLM020001 | K162273 | 000 |
| E314KNMLM0200010 | K162273 | 000 |
| E314KNMLM010001 | K162273 | 000 |
| E314KNMLM0100010 | K162273 | 000 |
| E314KNMLM010301 | K162273 | 000 |
| E314KNMLM0103010 | K162273 | 000 |
| E314KNMLM010401 | K162273 | 000 |
| E314KNMLM010101 | K162273 | 000 |