The following data is part of a premarket notification filed by Materialise Nv with the FDA for Materialise Shoulder Systemtm Materialise Shoulder Guide And Models Surgicase Shoulder Planner.
| Device ID | K220452 |
| 510k Number | K220452 |
| Device Name: | Materialise Shoulder SystemTM Materialise Shoulder Guide And Models SurgiCase Shoulder Planner |
| Classification | Shoulder Arthroplasty Implantation System |
| Applicant | Materialise NV Technologielaan 15 Leuven, BE 3001 |
| Contact | Jenny Jones |
| Correspondent | Jenny Jones 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 | 2022-02-17 |
| Decision Date | 2022-08-17 |