FDA Registration
Active
🇦🇺 Australia
Logical Acetabular Liner
Reg #: 3008262872
·
FEI: 3008262872
·
Expires 2025
Products
2
Proprietary Names
34
Establishment Types
1
Classifications
2
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
- K121297
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, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2013-01-17 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2013-01-17 |
Proprietary Names
Logical Acetabular Liner
Encina Taper Femoral Stem High Offset
BIOLOX Delta
Manza Polyethylene Liner
Encina HA Femoral Stem Standard Offset
CoCr Head
Encina HA Femoral Stem High Offset
Manza Heads
BIOLOX Forte
Encina Taper Femoral Stem Standard Offset
Logical Bone Screw
Logical G Series
Cup Apex Hole Cover
Manza Screws
NEO-T Stem
Encina HA Femoral Stem Standard Offset Collared
Aria Stem
Femoral Head
Tryon Liner
Kratos Stem
Logical PX Series
Logical Hole Cover
Origin Stem
Tryon Acetabular Cup
Fixation Screw
Manza Hole Cover
Sirocco Stem
Vento Cup
Stratus Stem
Cancellous Bone Screw
Logical XLPE Liner
Vento Fixation Screw
Ceramic Head
Vento XLPE Liner
Establishment Types
Manufacture Medical Device