FDA Registration
Active
🇩🇪 Germany
CREATEC GmbH & CO. KG
Reg #: 3006694268
·
FEI: 3006694268
·
Expires 2025
Products
3
Proprietary Names
0
Establishment Types
2
Classifications
3
Registration Details
- Registration Name
- CREATEC GmbH & CO. KG
- Registration Number
- 3006694268
- FEI Number
- 3006694268
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- ECKENERSTRASSE 65/6
- City
- FRIEDRICHSHAFEN Baden-Wurttemberg
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K170282
Owner / Operator
- Firm Name
- CREATEC LTD. & CO. KG
- Operator Number
- 9099162
- Address
- ECKENERSTRASSE 65/6, --
- City
- FRIEDRICHSHAFEN
- State
- DE-NOTA
- Postal Code
- D-88046
- Country
- DE
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2017-07-10 |
| Knee Arthroplasty Implantation System | OOG | Class 2 | Orthopedic | No | 2017-07-10 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2017-07-10 |
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device for Another Party (Contract Manufacturer)