ORTHOKEY ITALIA SRL
IT-MF-000026488 · Italy · CARRARA (MS)
ORTHOKEY ITALIA SRL is registered in the European database on medical devices as a manufacturer, with 83 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 83 |
|---|
Most frequent device types declared: ORTHOKEY Surgical instruments I, ORTHOKEY Surgical instruments IR, Robin Navigation.
Among these devices, 1 are declared sterile, 57 reusable, 4 active, 1 with a measuring function.
Devices declared under this manufacturer
- C-Clamp_DIA-20-32
- Cutting block adapter
- Extramedullary Jig Carbon
- Extramedullary Jig Vers.1
- Fixed Hip Star
- Knee Tip
- Perseus Cutting Guide 1.3 mm
- Perseus Device Sensor
- Pin Template Vers.1
- Removable femoral star
- Removable tibial star
- Robot Cart Star
Showing 12 of 83 declared devices.
Catalogue references include 20902402, 20902403, 20902501, 20912001, GS.N0220, GS.N0320.
European nomenclature codes declared: L0999, Z12011401, Z12020101.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 83 |
| Country of registration | Italy |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 83 |
|---|---|
| Found in the U.S. device database | 11 |
| Share | 13.3 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: Neither register. ORTHOKEY ITALIA SRL was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
IT348354 | issued | 2030-12-16 |