The following data is part of a premarket notification filed by Materialise N.v. with the FDA for Surgicase Connect, Surgicase Guide.
| Device ID | K112389 |
| 510k Number | K112389 |
| Device Name: | SURGICASE CONNECT, SURGICASE GUIDE |
| Classification | Orthopaedic Surgical Planning And Instrument Guides |
| 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 | PBF |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-18 |
| Decision Date | 2012-07-20 |
| Summary: | summary |