The following data is part of a premarket notification filed by Materialise N.v. with the FDA for Signature Planner / Signature Guides.
| Device ID | K110415 |
| 510k Number | K110415 |
| Device Name: | SIGNATURE PLANNER / SIGNATURE GUIDES |
| Classification | Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer |
| Applicant | MATERIALISE N.V. 15 TECHNOLOGIELAAN Leuven, BE 3001 |
| Contact | Alexandra Razzhivana |
| Correspondent | Alexandra Razzhivana MATERIALISE N.V. 15 TECHNOLOGIELAAN Leuven, BE 3001 |
| Product Code | HRY |
| Subsequent Product Code | JWH |
| Subsequent Product Code | MBH |
| Subsequent Product Code | OIY |
| Subsequent Product Code | OOG |
| CFR Regulation Number | 888.3530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-14 |
| Decision Date | 2011-05-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887868564727 | K110415 | 000 |
| E31442422751 | K110415 | 000 |
| E31442422752 | K110415 | 000 |
| E31442422753 | K110415 | 000 |
| E31442422760 | K110415 | 000 |
| E31442422761 | K110415 | 000 |
| E31442422762 | K110415 | 000 |
| E31442422763 | K110415 | 000 |
| E31442422770 | K110415 | 000 |
| E31442422771 | K110415 | 000 |
| E31442422772 | K110415 | 000 |
| E31442422750 | K110415 | 000 |
| E31442411574 | K110415 | 000 |
| 00887868564734 | K110415 | 000 |
| E31442411560 | K110415 | 000 |
| E31442411561 | K110415 | 000 |
| E31442411562 | K110415 | 000 |
| E31442411563 | K110415 | 000 |
| E31442411564 | K110415 | 000 |
| E31442411570 | K110415 | 000 |
| E31442411571 | K110415 | 000 |
| E31442411572 | K110415 | 000 |
| E31442411573 | K110415 | 000 |
| E31442422773 | K110415 | 000 |
| E314424115600 | K110415 | 000 |
| E314424227530 | K110415 | 000 |
| E314424227600 | K110415 | 000 |
| E314424227610 | K110415 | 000 |
| E314424227620 | K110415 | 000 |
| E314424227630 | K110415 | 000 |
| E314424227700 | K110415 | 000 |
| E314424227710 | K110415 | 000 |
| E314424227720 | K110415 | 000 |
| E314424227730 | K110415 | 000 |
| 00880304853034 | K110415 | 000 |
| E314424227520 | K110415 | 000 |
| E314424227510 | K110415 | 000 |
| E314424115610 | K110415 | 000 |
| E314424115620 | K110415 | 000 |
| E314424115630 | K110415 | 000 |
| E314424115640 | K110415 | 000 |
| E314424115700 | K110415 | 000 |
| E314424115710 | K110415 | 000 |
| E314424115720 | K110415 | 000 |
| E314424115730 | K110415 | 000 |
| E314424115740 | K110415 | 000 |
| E314424227500 | K110415 | 000 |
| 00880304853041 | K110415 | 000 |