FDA Registration
Active
🇦🇺 Australia
Corin Optimized Positioning System (OPS) Femoral
Reg #: 3012916784
·
FEI: 3012916784
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- OPTIMIZED ORTHO PTY LTD
- Registration Number
- 3012916784
- FEI Number
- 3012916784
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 17 Bridge Street
- City
- Sydney New South Wales
- Country
- AU
Regulatory Submissions
- 510(k) Number
- K181061
Owner / Operator
- Firm Name
- Optimized Ortho Pty Ltd
- Operator Number
- 10052254
- Address
- 17 Bridge Street
- City
- Sydney
- State
- New South Wales
- Postal Code
- 2073
- Country
- AU
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2018-09-17 |
| Orthopaedic Surgical Planning And Instrument Guides | PBF | Class 2 | Orthopedic | No | 2018-09-17 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2018-09-17 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | LWJ | Class 2 | Orthopedic | No | 2018-09-17 |
Proprietary Names
Corin Optimized Positioning System (OPS) Femoral
Establishment Types
Manufacture Medical Device