Manufacturer
Orthokey
ItalyLegal entities : ORTHOKEY ITALIA SRL
Markets : Italy · United States
Approvals : EU – class I, IIa · United States (FDA) – 510(k) : 1 · class II · latest in 2020 · see on the FDA website
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
- Click a category to see competitors, a model to open its EUDAMED record.
| Category | EMDN code | Registered models | Class | Contact |
|---|---|---|---|---|
| Surgical navigation system | Z12011401 |
|
I, IIa MDR, 93/42 | EUDAMED record Report an error |
| Robot-assisted endoscopic surgery systems | Z12020101 | I MDR | EUDAMED record Report an error |
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