FDA Registration
Active
🇲🇽 Mexico
MALLORY/HEAD TOTAL HIP SYSTEM; HA MALLORY/HEAD TOTAL HIP SYSTEM; BI-METRIC FEMORAL COMPONENTS
Reg #: 3006809628
·
FEI: 3006809628
·
Expires 2025
Products
2
Proprietary Names
1
Establishment Types
1
Classifications
2
Registration Details
- Registration Name
- Biomet Mexico
- Registration Number
- 3006809628
- FEI Number
- 3006809628
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Torre Jade Av. Periferico Sur No. 4829, 401. Col Parques del Pedregal,
- City
- Mexico City Ciudad de Mexico
- Country
- MX
Regulatory Submissions
- 510(k) Number
- K030055
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, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2018-01-23 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2018-01-23 |
Proprietary Names
MALLORY/HEAD TOTAL HIP SYSTEM; HA MALLORY/HEAD TOTAL HIP SYSTEM; BI-METRIC FEMORAL COMPONENTS
Establishment Types
Export Device to the United States But Perform No Other Operation on Device