Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K241143
Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner · Materialise NV · decided 2024-05-22 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| AtlasPlan | SHC-IN03-00-01 | Materialise NV | KWS PHX QHE | 05420060367069 |
| AtlasPlan | SHC-IN05-00-01 | Materialise NV | KWS PHX QHE | 05420060367120 |
| AtlasPlan | SHC-IN04-02-01 | Materialise NV | KWS PHX QHE | 05420060367106 |
| AtlasPlan | SHC-IN03-01-01 | Materialise NV | KWS PHX QHE | 05420060367076 |
| AtlasPlan | SHC-IN04-00-01 | Materialise NV | KWS PHX QHE | 05420060367083 |
| AtlasPlan | SHC-IN04-01-01 | Materialise NV | KWS PHX QHE | 05420060367090 |
| AtlasPlan | SHC-IN03-02-01 | Materialise NV | KWS PHX QHE | 05420060367052 |