Ortho Solutions UK Ltd
GB-MF-000030101 · United Kingdom · Maldon
Ortho Solutions UK Ltd is registered in the European database on medical devices as a manufacturer, with 115 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 44 |
|---|---|
| Class IIb | 71 |
Most frequent device types declared: Foot Plating Systems, Non-Invasive Devices and Accessories, Reusable Surgical Instruments, Rods Pins and Wires, Screw Systems.
Among these devices, 71 are declared sterile, 52 implantable, 44 reusable.
Authorised representative in the Union: Advena Limited.
Catalogue references include OS210100, OS211100, OS218150, OS220200, OS321107, OS328010.
European nomenclature codes declared: P09120301, S010401, P09120601, L0999, L0317, P09120101.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | Ortho Solutions UK Limited (GB) · FDA 3008951116 |
| Devices in EUDAMED | 115 |
| Country of registration | United Kingdom |
Device-level evidence
| Devices with a numeric GTIN | 115 |
|---|---|
| Found in the U.S. device database | 41 |
| Share | 35.7 % |
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. Ortho Solutions UK Ltd is registered in the United States but was not found in the Canadian register.