FDA Registration
Active
🇳🇱 Netherlands
ONE Planner Hip
Reg #: 3013564168
·
FEI: 3013564168
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- Biomet Global Supply Chain Center B.V. - Clinical Graphics
- Registration Number
- 3013564168
- FEI Number
- 3013564168
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Molengraaffsingel 8
- City
- Delft Zuid-Holland
- Country
- NL
Regulatory Submissions
- 510(k) Number
- K210653
Owner / Operator
- Firm Name
- Biomet, Inc.
- Operator Number
- 1825034
- Address
- 56 East Bell Dr., PO Box 587
- City
- Warsaw
- State
- IN
- Postal Code
- 46582
- 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, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive | PBI | Class 2 | Orthopedic | No | 2021-07-09 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2021-07-09 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2021-07-09 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2021-07-09 |
Proprietary Names
ONE Planner Hip
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)