FDA Registration
Active
🇺🇸 United States
Zimmer Knee Joint Replacement Prosthesis MR Labeling
Reg #: 2648920
·
FEI: 1000132037
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- ZIMMER MANUFACTURING B.V.
- Registration Number
- 2648920
- FEI Number
- 1000132037
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- ROUTE 1, KM. 123.4, BLDG. 2, TURPEAUX INDUSTRIAL PARK
- City
- MERCEDITA
- State
- PR
- ZIP
- 00715
- Country
- US
Regulatory Submissions
- 510(k) Number
- K173057
Owner / Operator
- Firm Name
- ZIMMER, INC.
- Operator Number
- 1822565
- Address
- 345 E. Main Street, --
- City
- Warsaw
- State
- IN
- Postal Code
- 46580
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer | KRR | Class 2 | Orthopedic | No | 2018-04-03 |
| Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | KRO | Class 2 | Orthopedic | No | 2018-04-03 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2018-04-03 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2018-04-03 |
Proprietary Names
Zimmer Knee Joint Replacement Prosthesis MR Labeling
Establishment Types
Manufacture Medical Device