FDA Registration
Active
🇨🇷 Costa Rica
Comprehensive Segmental Revision System (SRS)
Reg #: 3014315560
·
FEI: 3014315560
·
Expires 2025
Products
5
Proprietary Names
1
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- Zimmer Biomet Centroamerica SA
- Registration Number
- 3014315560
- FEI Number
- 3014315560
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Oficentro Ejecutivo La Sabana, Edificio 7, Piso 3
- City
- san jose
- Country
- CR
Regulatory Submissions
- 510(k) Number
- K173411
Owner / Operator
- Firm Name
- ZimmerBiomet Americas DFE
- Operator Number
- 10056779
- Address
- 1800 W Center St.
- 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 | 2020-09-14 |
| Prosthesis, Elbow, Constrained, Cemented | JDC | Class 2 | Orthopedic | No | 2020-09-14 |
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | Class 2 | Orthopedic | No | 2020-09-14 |
| Shoulder Prosthesis, Reverse Configuration | PHX | Class 2 | Orthopedic | No | 2020-09-14 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | MBF | Class 2 | Orthopedic | No | 2020-09-14 |
Proprietary Names
Comprehensive Segmental Revision System (SRS)
Establishment Types
Export Device to the United States But Perform No Other Operation on Device