Adler Ortho S.p.A
IT-MF-000010164 · Italy · Cormano (MI)
Adler Ortho S.p.A is registered in the European database on medical devices as a manufacturer, with 2 786 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIb | 786 |
|---|---|
| Class I | 2 000 |
Most frequent device types declared: APTA-FIX ANATOMICAL CEMENTLESS STEM Ti+HA COATED NECK 12/14 WITH OFFSE, GENUS ANTI-ALLERGIC TiNbN COATED CEMENTED FEMORAL COMPONENT SIZE 3 STA, GENUS CEMENTED FEMORAL COMPONENT SIZE 6 NARROW LEFT, GENUS FIXED CEMENTED CoCrMo TIBIAL TRAY SIZE 7, GENUS PANTHEON 6 mm OFFSET CONNECTOR +30 mm.
Among these devices, 2 786 are declared sterile, 2 784 implantable, 1 active.
Devices declared under this manufacturer
- AGILIS
- APTA STEM
- APTA-FIX STEM
- BIS MOBILITY
- CERAMIC HEADS
- DREAM
- DUPLEX
- FIXA LARUS
- FOOT SCREWS
- GENUS
- GENUS PANTHEON
- NAVICULA
Showing 12 of 2 786 declared devices.
Catalogue references include 0101503, 1138996, 1188923, 1648007, 1768012, 1872004.
European nomenclature codes declared: P0909030102, P09098002, P0909030101, P090905020201, P090204, P0909800602.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | ADLER ORTHO S.P.A. (IT) · FDA 3008281151 |
| Devices in EUDAMED | 2 786 |
| Country of registration | Italy |
Device-level evidence
| Devices with a numeric GTIN | 2 785 |
|---|---|
| Found in the U.S. device database | 110 |
| Share | 3.9 % |
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: United States only. Adler Ortho S.p.A is registered in the United States but was not found in the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
001-00-01-MDR | supplemented | 2027-03-31 |