FDA Registration
Active
🇬🇧 United Kingdom
ORTHOPLASTICS LTD
Reg #: 3000264985
·
FEI: 3000264985
·
Expires 2025
Products
2
Proprietary Names
0
Establishment Types
1
Classifications
2
Registration Details
- Registration Name
- ORTHOPLASTICS LTD
- Registration Number
- 3000264985
- FEI Number
- 3000264985
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Grove Mill, Todmorden Road
- City
- Bacup Lancashire
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K160342
Owner / Operator
- Firm Name
- Orthoplastics Ltd
- Operator Number
- 10054760
- Address
- Grove Mill, Todmorden Road
- City
- Bacup
- State
- Lancashire
- Postal Code
- OL13 9EF
- Country
- GB
US Agent
- Business Name
- Registrar Corp
- Contact Name
- David Lennarz
- Address
- 144 Research Drive
- City
- Hampton
- State
- VA
- ZIP
- 23666
- Country
- US
- [email protected]
- Phone
- 757 2240177
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2017-12-13 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | OIY | Class 2 | Orthopedic | No | 2017-12-13 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)