FDA Registration
Active
🇬🇧 United Kingdom
ORTHOPLASTICS LTD
Reg #: 3000264985
·
FEI: 3000264985
·
Expires 2026
Products
17
Proprietary Names
13
Establishment Types
1
Classifications
17
Registration Details
- Registration Name
- ORTHOPLASTICS LTD
- Registration Number
- 3000264985
- FEI Number
- 3000264985
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Grove Mill, Todmorden Road
- City
- Bacup Lancashire
- Country
- GB
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 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | KWZ | Class 2 | Orthopedic | No | 2017-12-13 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2017-12-13 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented | PAO | Class 2 | Orthopedic | No | 2017-12-13 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2017-12-13 |
| Shoulder Prosthesis, Reverse Configuration | PHX | Class 2 | Orthopedic | No | 2024-03-29 |
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | Class 2 | Orthopedic | No | 2024-03-29 |
| Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | OQG | Class 2 | Orthopedic | No | 2019-07-09 |
| Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | OQI | Class 2 | Orthopedic | No | 2019-07-09 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2019-07-09 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2019-07-09 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2024-07-18 |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | HSX | Class 2 | Orthopedic | No | 2024-07-18 |
| Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer | KRR | Class 2 | Orthopedic | No | 2024-07-18 |
| Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | KRO | Class 2 | Orthopedic | No | 2017-04-24 |
| Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Trunnion-Bearing | LGE | Class 2 | Orthopedic | No | 2017-04-24 |
Proprietary Names
FX Solutions Humelock II Humeral Cup Stability & Humeral CUp 135/145 Stability
Arthrex iBalance Bicompartmental Arthroplasty System
Arthrex iBalance PFJ
Arthrex iBalance UKA System
Arthrex iBalance TKA System
Patellar Component
Arthrex Univers Revers CA Heads and Adapters
FX Solutions Humelock II 32mm Glenosphere and Humeral Cup
FX Solutions Humelock II Reversible Shoulder System
Triathlon Knee System
Univers Revers CA Head Adapter
Univers Revers CA Head
FX Solutions Humeris 135 Shoulder System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)