OrthoXel DAC
IE-MF-000000574 · Ireland · Cork
OrthoXel DAC is registered in the European database on medical devices as a manufacturer, with 786 devices declared. It has a similarly named entry in the FDA register that we have not verified.
What this manufacturer declares
| Class IIb | 643 |
|---|---|
| Class IIa | 143 |
Most frequent device types declared: F01-130440, F03-115420, F04-130340, F04-850340, F05-100300.
Among these devices, 644 are declared sterile, 643 implantable, 142 reusable, 1 active.
Devices declared under this manufacturer
- Apex Femoral Nail GT Left Ø 10.0 x 380mm
- Apex Femoral Nail GT Left Ø 11.5 x 420mm
- Apex Femoral Nail GT Right Ø 13.0 x 340mm
- Apex Femoral Nail GT Right Ø 14.5 x 460mm
- Apex Femoral Nail GT Right Ø 8.5 x 340mm
- Apex Femoral Nail PF Left Ø 13.0 x 440mm
- Apex Femoral Nail Retrograde Ø 10.0 x 300mm
- Apex Locking Endcap Tibial/Retrograde 0mm Length
- Apex Tibial Nail Ø 12 x 270mm
- Apex Tibial Nail Ø 12 x 390mm
- Apex Tibial Nail Ø 13 x 345mm
- Modular T-Handle
Showing 12 of 786 declared devices.
Catalogue references include F01-130440, F03-115420, F04-130340, F04-850340, F05-100300, INS-1070.
European nomenclature codes declared: P09120201, L0999, V9012.
United States market access
| FDA establishment register | Similar name found — unverified |
|---|---|
| Matched entry | ORTHOXEL (IE) · FDA 3014976005 |
| Devices in EUDAMED | 786 |
| Country of registration | Ireland |
⚠️ A similar name exists; we do not assert it is the same company — why.
Device-level evidence
| Devices with a numeric GTIN | 786 |
|---|---|
| Found in the U.S. device database | 769 |
| Share | 97.8 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.