Ortho Solutions UK, Ltd.
Active in EUDAMEDUnited Kingdomfrom SRN EUDAMED FDA SRN GB-MF-000030101
- Devices
- 82
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA establishment
What Ortho Solutions UK, Ltd. makes
Ortho Solutions UK, Ltd. manufactures orthopedic fixation systems, including the Succession AFN System for fracture stabilization, the Ortho Solutions Plating System for bone plate fixation, the COGNiTiON Staple System for internal fixation, and the Volition Plating System for modular plating applications.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Search and filter all 82 devicesShowing 1-50 of 82
Company details
- EUDAMED SRN
- GB-MF-000030101
- EUDAMED status
- Active
- EUDAMED registered name
- Ortho Solutions UK Ltd
- Registered address
- Unit 5, West Station Business Park, CM9 6FF, Maldon, United Kingdom (ex Northern Ireland)
- Website
- orthosol.com/?region=row
- [email protected]
- Phone
- +44(0)1621 843599
- PRRC contact
- JESIN SYNTHEE
FDA establishments
- Ortho Solutions UK Limited Maldon Essex · GB FEI 3008951116
Frequently asked questions
How many devices does Ortho Solutions UK, Ltd. have in the registry?
The registry currently lists 82 devices for Ortho Solutions UK, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ortho Solutions UK, Ltd.'s devices?
Among its 50 most recently registered devices, Ortho Solutions UK, Ltd. has devices listed in EUDAMED (50 devices).
What risk classes do Ortho Solutions UK, Ltd.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Ortho Solutions UK, Ltd.'s devices are Class I and Class IIb. Each device page shows its own class and authorisation.
What are the newest devices from Ortho Solutions UK, Ltd. in the registry?
The most recently registered devices listed for Ortho Solutions UK, Ltd. include Screws and Washers, Implantable Wires and Class I Instruments.
Which FDA establishments are linked to Ortho Solutions UK, Ltd.?
1 FDA establishment is linked to Ortho Solutions UK, Ltd. in the registry; they are listed on the company page.