FDA Registration
Active
🇺🇸 United States
Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplaste, Comprehensive Mini Baseplate
Reg #: 1822565
·
FEI: 1000220733
·
Expires 2025
Products
5
Proprietary Names
1
Establishment Types
1
Classifications
5
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
- K172502
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 |
|---|---|---|---|---|---|
| Shoulder Prosthesis, Reverse Configuration | PHX | Class 2 | Orthopedic | No | 2018-01-10 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2018-01-10 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented | PAO | Class 2 | Orthopedic | No | 2018-01-10 |
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | Class 2 | Orthopedic | No | 2018-01-10 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | MBF | Class 2 | Orthopedic | No | 2018-01-10 |
Proprietary Names
Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplaste, Comprehensive Mini Baseplate
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)