FDA Registration
Active
🇨🇳 China
ALTRA FX HIP SYSTEM
Reg #: 3007923096
·
FEI: 3007923096
·
Expires 2025
Products
11
Proprietary Names
1
Establishment Types
1
Classifications
11
Registration Details
- Registration Name
- Changzhou Biomet Medical Devices Co., Ltd.
- Registration Number
- 3007923096
- FEI Number
- 3007923096
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No. 235 Chuangxin Road, EPZ Xinbei District
- City
- Changzhou City Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K063614
Owner / Operator
- Firm Name
- Biomet, Inc.
- Operator Number
- 1825034
- Address
- 56 East Bell Dr., PO Box 587
- City
- Warsaw
- State
- IN
- Postal Code
- 46582
- Country
- US
US Agent
- Business Name
- Zimmer Biomet
- Contact Name
- Holly Seppanen
- Address
- 1800 West Center Street
- 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, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2008-02-05 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | KWZ | Class 2 | Orthopedic | No | 2008-02-05 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2008-02-05 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish | MAY | Class 2 | Orthopedic | No | 2008-02-05 |
| Prosthesis, Hip, Hemi-, Femoral, Metal | KWL | Class 2 | Orthopedic | No | 2008-02-05 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2008-02-05 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | LWJ | Class 2 | Orthopedic | No | 2008-02-05 |
| Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) | JDL | Class 3 | Orthopedic | No | 2008-02-05 |
| Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | KWA | Class 3 | Orthopedic | No | 2008-02-05 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2008-02-05 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2008-02-05 |
Proprietary Names
ALTRA FX HIP SYSTEM
Establishment Types
Manufacture Medical Device