FDA Registration
Active
🇮🇪 Ireland
Femoral Head
Reg #: 3014763043
·
FEI: 3014763043
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Signature Orthopaedics Europe Ltd
- Registration Number
- 3014763043
- FEI Number
- 3014763043
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Unit A, IDA Business & Technology Park, Garrycastle
- City
- Athlone Westmeath
- Country
- IE
Regulatory Submissions
- 510(k) Number
- K163081
Owner / Operator
- Firm Name
- Signature Orthopaedics Pty Limited
- Operator Number
- 10037793
- Address
- 7 Sirius Road
- City
- Lane Cove West
- State
- New South Wales
- Postal Code
- 2066
- Country
- AU
- Correspondent
- Declan P Brazil
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2018-04-25 |
Proprietary Names
Femoral Head
BiPolar Head
Establishment Types
Manufacture Medical Device