FDA Registration
Active
🇨🇦 Canada
Zimmer PSI Shoulder System
Reg #: 9617840
·
FEI: 3003714383
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- ZIMMER CAS
- Registration Number
- 9617840
- FEI Number
- 3003714383
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 75 QUEEN ST., SUITE 3300
- City
- MONTREAL, QUEBEC
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K150730
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, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2015-06-18 |
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | Class 2 | Orthopedic | No | 2015-06-18 |
| Shoulder Prosthesis, Reverse Configuration | PHX | Class 2 | Orthopedic | No | 2015-06-18 |
Proprietary Names
Zimmer PSI Shoulder System
Establishment Types
Manufacture Medical Device