FDA Registration
Active
🇧🇷 Brazil
ANA0TOMICAL SHOULDER TM COMBINED SYSTEM
Reg #: 3013086329
·
FEI: 3013086329
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- WM WORLD MEDICAL IMPORTACAO E EXPORTACAO LTDA.
- Registration Number
- 3013086329
- FEI Number
- 3013086329
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Rua do Rezende, 189, Centro
- City
- Rio de Janeiro
- Country
- BR
Regulatory Submissions
- 510(k) Number
- K103404
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 W Center St.
- 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, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2023-03-24 |
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | Class 2 | Orthopedic | No | 2023-03-24 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2023-03-24 |
Proprietary Names
ANA0TOMICAL SHOULDER TM COMBINED SYSTEM
Establishment Types
Export Device to the United States But Perform No Other Operation on Device