FDA Registration
Active
🇦🇺 Australia
G7 Acetabular System
Reg #: 3035366890
·
FEI: 3035366890
·
Expires 2025
Products
8
Proprietary Names
1
Establishment Types
1
Classifications
8
Registration Details
- Registration Name
- Zimmer Biomet Pty Ltd
- Registration Number
- 3035366890
- FEI Number
- 3035366890
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Level 4, 12 Narabang Way, Belrose, NSW
- City
- Sydney New South Wales
- Country
- AU
Regulatory Submissions
- 510(k) Number
- K121874
Owner / Operator
- Firm Name
- Zimmer Biomet APAC DFE
- Operator Number
- 10056128
- Address
- Zimmer Biomet Shanghai
- City
- Shanghai
- State
- CN-SH
- Postal Code
- 200051
- Country
- CN
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | KWZ | Class 2 | Orthopedic | No | 2018-08-14 |
| Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | OQI | Class 2 | Orthopedic | No | 2018-08-14 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2018-08-14 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2018-08-14 |
| Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | OQG | Class 2 | Orthopedic | No | 2018-08-14 |
| Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented | OQH | Class 2 | Orthopedic | No | 2018-08-14 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive | PBI | Class 2 | Orthopedic | No | 2018-08-14 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2018-08-14 |
Proprietary Names
G7 Acetabular System
Establishment Types
Export Device to the United States But Perform No Other Operation on Device