The following data is part of a premarket notification filed by Materialise Nv with the FDA for Materialise Shoulder System™, Materialise Shoulder Guide And Models, Surgicase Shoulder Planner.
| Device ID | K212569 |
| 510k Number | K212569 |
| Device Name: | Materialise Shoulder System™, Materialise Shoulder Guide And Models, SurgiCase Shoulder Planner |
| Classification | Shoulder Arthroplasty Implantation System |
| Applicant | Materialise NV Technologielaan 15 Leuven, BE 3001 |
| Contact | Simona Beri |
| Correspondent | Simona Beri Materialise NV Technologielaan 15 Leuven, BE 3001 |
| Product Code | QHE |
| Subsequent Product Code | KWS |
| Subsequent Product Code | PHX |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-16 |
| Decision Date | 2022-01-12 |