FDA Registration
Active
🇬🇧 United Kingdom
Cerclage Wire
Reg #: 3008951116
·
FEI: 3008951116
·
Expires 2025
Products
5
Proprietary Names
14
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- Ortho Solutions UK Limited
- Registration Number
- 3008951116
- FEI Number
- 3008951116
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- West Station Business Park, Spital Road
- City
- Maldon Essex
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K110895
Owner / Operator
- Firm Name
- Ortho Solutions UK Ltd
- Operator Number
- 10035321
- Address
- West Station Buisness Park, Spital Road
- City
- Maldon
- State
- Essex
- Postal Code
- CM96FF
- Country
- GB
- Correspondent
- Jesin Synthee
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2012-01-11 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2012-01-11 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2012-01-11 |
| Cerclage, Fixation | JDQ | Class 2 | Orthopedic | No | 2012-01-11 |
| Pin, Fixation, Threaded | JDW | Class 2 | Orthopedic | No | 2012-01-11 |
Proprietary Names
Cerclage Wire
Steinman Pins - Smooth, Threaded & Calibrated
Fixation Pins
Cannulated Bone Screw Systems
Rush Pins
Denham Pins
Flexible Guide Wires
K-Wires - Smooth & Threaded
Nailing Guide Pins
Guide Pins
ACL/PCL Passing Pins
Schanz Screws
Nailing Rods
Mini Hoffman Pins
Establishment Types
Manufacture Medical Device