FDA Registration
Active
🇮🇪 Ireland
Persona Partial Knee System
Reg #: 3007963827
·
FEI: 3007963827
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Zimmer Orthopedic Mfg Ltd
- Registration Number
- 3007963827
- FEI Number
- 3007963827
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Building No 2 East Park, Shannon Industrial Estate
- City
- Shannon Clare
- Country
- IE
Regulatory Submissions
- 510(k) Number
- K161592
Owner / Operator
- Firm Name
- ZIMMER, INC.
- Operator Number
- 1822565
- Address
- 345 E. Main Street, --
- City
- Warsaw
- State
- IN
- Postal Code
- 46580
- Country
- US
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, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | HSX | Class 2 | Orthopedic | No | 2016-11-09 |
Proprietary Names
Persona Partial Knee System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)