The following data is part of a premarket notification filed by Materialise Nv with the FDA for Surgicase Orthopaedics, Surgicase Connect, Surgicase Guides.
| Device ID | K163156 |
| 510k Number | K163156 |
| Device Name: | SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides |
| Classification | Orthopaedic Surgical Planning And Instrument Guides |
| Applicant | Materialise NV Technologielaan 15 Leuven, BE 3001 |
| Contact | Oliver Clemens |
| Correspondent | Oliver Clemens Materialise NV Technologielaan 15 Leuven, BE 3001 |
| Product Code | PBF |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-10 |
| Decision Date | 2017-01-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E314UEAMA0100010 | K163156 | 000 |
| 05420060343346 | K163156 | 000 |
| 05420060343278 | K163156 | 000 |