The following data is part of a premarket notification filed by Materialise N.v. with the FDA for Signature Planner; Signature Guides.
| Device ID | K102795 |
| 510k Number | K102795 |
| Device Name: | SIGNATURE PLANNER; SIGNATURE GUIDES |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | MATERIALISE N.V. TECHNOLOGIELAAN 15 Leuven, BE 3001 |
| Contact | Alexandra Razzhivina |
| Correspondent | Alexandra Razzhivina 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 | 2010-09-27 |
| Decision Date | 2011-02-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887868507120 | K102795 | 000 |
| E31442422567 | K102795 | 000 |
| E31442422568 | K102795 | 000 |
| E31442422570 | K102795 | 000 |
| E31442422571 | K102795 | 000 |
| E31442422572 | K102795 | 000 |
| E31442422573 | K102795 | 000 |
| E31442422575 | K102795 | 000 |
| E31442422576 | K102795 | 000 |
| E31442422577 | K102795 | 000 |
| E31442422578 | K102795 | 000 |
| E314424225500 | K102795 | 000 |
| E314424225510 | K102795 | 000 |
| E314424225520 | K102795 | 000 |
| E314424225530 | K102795 | 000 |
| E31442422566 | K102795 | 000 |
| E31442422565 | K102795 | 000 |
| E31442422563 | K102795 | 000 |
| 00887868507137 | K102795 | 000 |
| 00887868507144 | K102795 | 000 |
| 00887868273407 | K102795 | 000 |
| E31442422550 | K102795 | 000 |
| E31442422551 | K102795 | 000 |
| E31442422552 | K102795 | 000 |
| E31442422553 | K102795 | 000 |
| E31442422555 | K102795 | 000 |
| E31442422556 | K102795 | 000 |
| E31442422557 | K102795 | 000 |
| E31442422558 | K102795 | 000 |
| E31442422560 | K102795 | 000 |
| E31442422561 | K102795 | 000 |
| E31442422562 | K102795 | 000 |
| E314424225550 | K102795 | 000 |
| E314424225560 | K102795 | 000 |
| E314424225780 | K102795 | 000 |
| 00880304459946 | K102795 | 000 |
| 00880304459953 | K102795 | 000 |
| 00880304460225 | K102795 | 000 |
| 00880304467026 | K102795 | 000 |
| 00880304497320 | K102795 | 000 |
| 00880304507104 | K102795 | 000 |
| 00880304716384 | K102795 | 000 |
| 00880304716391 | K102795 | 000 |
| 00880304716407 | K102795 | 000 |
| 00880304716414 | K102795 | 000 |
| 00880304716421 | K102795 | 000 |
| 00880304716438 | K102795 | 000 |
| 00880304927490 | K102795 | 000 |
| E314424225770 | K102795 | 000 |
| E314424225760 | K102795 | 000 |
| E314424225750 | K102795 | 000 |
| E314424225570 | K102795 | 000 |
| E314424225580 | K102795 | 000 |
| E314424225600 | K102795 | 000 |
| E314424225610 | K102795 | 000 |
| E314424225620 | K102795 | 000 |
| E314424225630 | K102795 | 000 |
| E314424225650 | K102795 | 000 |
| E314424225660 | K102795 | 000 |
| E314424225670 | K102795 | 000 |
| E314424225680 | K102795 | 000 |
| E314424225700 | K102795 | 000 |
| E314424225710 | K102795 | 000 |
| E314424225720 | K102795 | 000 |
| E314424225730 | K102795 | 000 |
| 00880304928510 | K102795 | 000 |