The following data is part of a premarket notification filed by Materialise N.v. with the FDA for Materialise Tka Guide System, Materialise Tka Planner, Materialise Tka Guides.
| Device ID | K150928 |
| 510k Number | K150928 |
| Device Name: | Materialise TKA Guide System, Materialise TKA Planner, Materialise TKA Guides |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | MATERIALISE N.V. TECHNOLOGIELAAN 15 Leuven, BE 3001 |
| Contact | Laurel Berzanskis |
| Correspondent | Laurel Berzanskis MATERIALISE N.V. 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 | 2015-04-06 |
| Decision Date | 2015-08-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E314KNMCO0600010 | K150928 | 000 |
| E314SURGICASEPLANNER0 | K150928 | 000 |
| E314SURGICASEKNEEPLAN0 | K150928 | 000 |
| E314KNMCO0400010 | K150928 | 000 |
| E314KNMCO040001 | K150928 | 000 |
| E314KNMCO0200010 | K150928 | 000 |
| E314KNMCO020001 | K150928 | 000 |
| E314KNMCO0102010 | K150928 | 000 |
| E314KNMCO010201 | K150928 | 000 |
| E314KNMCO0101010 | K150928 | 000 |
| E314KNMCO010001 | K150928 | 000 |
| E314KNMCO0100010 | K150928 | 000 |
| E314KNMCO060001 | K150928 | 000 |
| E314KNMCO0500010 | K150928 | 000 |
| E314KNMCO050001 | K150928 | 000 |
| E314KNMCO0300010 | K150928 | 000 |
| E314KNMCO030001 | K150928 | 000 |
| E314KNMCO0104010 | K150928 | 000 |
| E314KNMCO010401 | K150928 | 000 |
| E314KNMCO0103010 | K150928 | 000 |
| E314KNMCO010301 | K150928 | 000 |
| E314KNMCO010101 | K150928 | 000 |