FDA Registration
Active
🇦🇺 Australia
Origin TT
Reg #: 3008262872
·
FEI: 3008262872
·
Expires 2025
Products
8
Proprietary Names
1
Establishment Types
1
Classifications
8
Registration Details
- Registration Name
- SIGNATURE ORTHOPAEDICS PTY LIMITED
- Registration Number
- 3008262872
- FEI Number
- 3008262872
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 7 Sirius Road, Lane Cove West
- City
- Sydney New South Wales
- Country
- AU
Regulatory Submissions
- 510(k) Number
- K243029
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 | 2025-03-12 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | KWZ | Class 2 | Orthopedic | No | 2025-03-12 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2025-03-12 |
| Prosthesis, Hip, Hemi-, Femoral, Metal | KWL | Class 2 | Orthopedic | No | 2025-03-12 |
| Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | OQG | Class 2 | Orthopedic | No | 2025-03-12 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2025-03-12 |
| Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | OQI | Class 2 | Orthopedic | No | 2025-03-12 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2025-03-12 |
Proprietary Names
Origin TT
Establishment Types
Manufacture Medical Device