FDA Registration
Active
🇯🇵 Japan
Lateralized Taperloc® Microplasty Femoral Components
Reg #: 3012725451
·
FEI: 3012725451
·
Expires 2025
Products
9
Proprietary Names
1
Establishment Types
1
Classifications
9
Registration Details
- Registration Name
- Zimmer Biomet G.K.
- Registration Number
- 3012725451
- FEI Number
- 3012725451
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 6-15 Shinmachi
- City
- Hiratsuka Kanagawa
- Country
- JP
Regulatory Submissions
- 510(k) Number
- K062994
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
- 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 | 2018-08-13 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2018-08-13 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous | MBL | Class 2 | Orthopedic | No | 2018-08-13 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2018-08-13 |
| Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | KWA | Class 3 | Orthopedic | No | 2018-08-13 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | KWZ | Class 2 | Orthopedic | No | 2018-08-13 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2018-08-13 |
| Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) | JDL | Class 3 | Orthopedic | No | 2018-08-13 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2018-08-13 |
Proprietary Names
Lateralized Taperloc® Microplasty Femoral Components
Establishment Types
Export Device to the United States But Perform No Other Operation on Device