FDA Registration
Active
🇨🇳 China
Biomet Knee Joint Replacement Prostheses
Reg #: 3015207155
·
FEI: 3015207155
·
Expires 2025
Products
5
Proprietary Names
1
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- Zimmer (Shanghai) Medical International Trading Co., Ltd.
- Registration Number
- 3015207155
- FEI Number
- 3015207155
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Ground Floor 129 North Fu Te Road Pilot Free Trade Zone Pudong District
- City
- Shanghai
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K171054
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
US Agent
- Business Name
- Zimmer Biomet
- Contact Name
- Holly Seppanen
- Address
- 1800 West Center Street, Warsaw, IN US 46580
- City
- Warsaw
- State
- IN
- ZIP
- 46580
- Country
- US
- [email protected]
- Phone
- 952 8470494
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | HRY | Class 2 | Orthopedic | No | 2018-08-14 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | OIY | Class 2 | Orthopedic | No | 2018-08-14 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2018-08-14 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer | MBV | Class 2 | Orthopedic | No | 2018-08-14 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2018-08-14 |
Proprietary Names
Biomet Knee Joint Replacement Prostheses
Establishment Types
Export Device to the United States But Perform No Other Operation on Device