FDA Registration
Active
🇬🇧 United Kingdom
Bone Plate/Screw/Washer - Large Fragment (LFS)
Reg #: 3008951116
·
FEI: 3008951116
·
Expires 2025
Products
4
Proprietary Names
5
Establishment Types
1
Classifications
4
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
- K120360
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 |
|---|---|---|---|---|---|
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2012-08-10 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2012-08-10 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2012-08-10 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2012-08-10 |
Proprietary Names
Bone Plate/Screw/Washer - Large Fragment (LFS)
CHS/SCS Compression Plate
Bone Plate/Screw/Washer - Mini Fragment (MFS)
Systems
Bone Plate/Screw/Washer - Small Fragment (SFS)
Establishment Types
Manufacture Medical Device