FDA Registration
Active
🇺🇸 United States
Fitmore Hip Stem
Reg #: 1822565
·
FEI: 1000220733
·
Expires 2025
Products
6
Proprietary Names
1
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- ZIMMER, INC.
- Registration Number
- 1822565
- FEI Number
- 1000220733
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 1800 W. Center Street
- City
- WARSAW
- State
- IN
- ZIP
- 46580
- Country
- US
Regulatory Submissions
- 510(k) Number
- K170072
Owner / Operator
- Firm Name
- ZIMMER, INC.
- Operator Number
- 1822565
- Address
- 345 E. Main Street, --
- City
- Warsaw
- State
- IN
- Postal Code
- 46580
- Country
- US
- Correspondent
- Kevin Escapule
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2017-02-13 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | LWJ | Class 2 | Orthopedic | No | 2017-02-13 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | KWZ | Class 2 | Orthopedic | No | 2017-02-13 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2017-02-13 |
| Prosthesis, Hip, Hemi-, Femoral, Metal | KWL | Class 2 | Orthopedic | No | 2017-02-13 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2017-02-13 |
Proprietary Names
Fitmore Hip Stem
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)