The following data is part of a premarket notification filed by Materialise N.v. with the FDA for Surgicase Cmf, Surgicase Connect, Surgicase Guide.
| Device ID | K103136 |
| 510k Number | K103136 |
| Device Name: | SURGICASE CMF, SURGICASE CONNECT, SURGICASE GUIDE |
| Classification | Plate, Bone |
| Applicant | MATERIALISE N.V. 15 TECHNOLOGIELAAN Leuven, BE 3001 |
| Contact | Alexandra Razzhivina |
| Correspondent | Alexandra Razzhivina MATERIALISE N.V. 15 TECHNOLOGIELAAN Leuven, BE 3001 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-25 |
| Decision Date | 2011-03-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05420060351112 | K103136 | 000 |
| 05420060350030 | K103136 | 000 |
| 05420060350047 | K103136 | 000 |
| 05420060350061 | K103136 | 000 |
| 05420060350085 | K103136 | 000 |
| 05420060350092 | K103136 | 000 |
| 05420060350511 | K103136 | 000 |
| 05420060350542 | K103136 | 000 |
| 05420060350566 | K103136 | 000 |
| 05420060351013 | K103136 | 000 |
| 05420060351020 | K103136 | 000 |
| 05420060351044 | K103136 | 000 |
| 05420060351051 | K103136 | 000 |
| 05420060351068 | K103136 | 000 |
| 05420060351075 | K103136 | 000 |
| 05420060350016 | K103136 | 000 |