FDA Registration
Active
🇩🇪 Germany
CERAMTEC GmbH Medical Products Division
Reg #: 8044172
·
FEI: 3002806653
·
Expires 2025
Products
1
Proprietary Names
0
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- CERAMTEC GmbH Medical Products Division
- Registration Number
- 8044172
- FEI Number
- 3002806653
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- CeramTec-Platz 1-9 Building K
- City
- PLOCHINGEN Baden-Wurttemberg
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K060918
Owner / Operator
- Firm Name
- CeramTec GmbH
- Operator Number
- 9066049
- Address
- CeramTec-Platz 1-9
- City
- Plochingen
- State
- Baden-Wurttemberg
- Postal Code
- D-73207
- Country
- DE
- Correspondent
- Stefan - Ruck
US Agent
- Business Name
- CeramTec GmbH
- Contact Name
- Lindsay Stafford
- Address
- 1350 N Santorini Dr
- City
- Warsaw
- State
- IN
- ZIP
- 46580
- Country
- US
- [email protected]
- Phone
- 864 6842253
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2007-12-07 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)