The following data is part of a premarket notification filed by Materialise N.v. with the FDA for Surgicase Orthopaedics System, Surgicase Connect, Surgicase Guides.
| Device ID | K132290 |
| 510k Number | K132290 |
| Device Name: | SURGICASE ORTHOPAEDICS SYSTEM, SURGICASE CONNECT, SURGICASE GUIDES |
| Classification | Orthopaedic Surgical Planning And Instrument Guides |
| Applicant | MATERIALISE N.V. TECHNOLOGIELAAN 15 Leuven, BE 3001 |
| Contact | Oliver Clemens |
| Correspondent | Oliver Clemens MATERIALISE N.V. 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 | 2013-07-23 |
| Decision Date | 2014-04-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E314SURGICASECONNECT0 | K132290 | 000 |
| E314O01030600000110100 | K132290 | 000 |
| E314O0103060000011010 | K132290 | 000 |
| E314O01030300000110100 | K132290 | 000 |
| E314O0103030000011010 | K132290 | 000 |