FDA Registration
Active
🇬🇧 United Kingdom
Sterile Drill Bits
Reg #: 3008951116
·
FEI: 3008951116
·
Expires 2025
Products
4
Proprietary Names
6
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
- K102743
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 |
|---|---|---|---|---|---|
| Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment | HSZ | Class 1 | General, Plastic Surgery | No | 2011-02-19 |
| Bur, Surgical, General & Plastic Surgery | GFF | Class 1 | General, Plastic Surgery | No | 2011-02-19 |
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | Class 1 | General, Plastic Surgery | No | 2011-02-19 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2011-02-19 |
Proprietary Names
Sterile Drill Bits
Sterile Saw Blades
Sterile Taps
Sterile Burrs
Sterile Gigli Saws
Sterile Countersinks
Establishment Types
Manufacture Medical Device