FDA Registration
Active
🇺🇸 United States
G7 ACETABULAR SYSTEM-LTF Zimmer Design Control
Reg #: 2648920
·
FEI: 1000132037
·
Expires 2025
Products
8
Proprietary Names
1
Establishment Types
1
Classifications
8
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
- K121874
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 |
|---|---|---|---|---|---|
| Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | OQG | Class 2 | Orthopedic | No | 2020-06-19 |
| Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | OQI | Class 2 | Orthopedic | No | 2020-06-19 |
| Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented | OQH | Class 2 | Orthopedic | No | 2020-06-19 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive | PBI | Class 2 | Orthopedic | No | 2020-06-19 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | KWZ | Class 2 | Orthopedic | No | 2020-06-19 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2020-06-19 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2020-06-19 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2020-06-19 |
Proprietary Names
G7 ACETABULAR SYSTEM-LTF Zimmer Design Control
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)