FDA Registration
Active
🇩🇪 Germany
CREATEC GmbH & CO. KG
Reg #: 3006694268
·
FEI: 3006694268
·
Expires 2026
Products
20
Proprietary Names
1
Establishment Types
2
Classifications
20
Registration Details
- Registration Name
- CREATEC GmbH & CO. KG
- Registration Number
- 3006694268
- FEI Number
- 3006694268
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- ECKENERSTRASSE 65/6
- City
- FRIEDRICHSHAFEN Baden-Wurttemberg
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K202099
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 |
|---|---|---|---|---|---|
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2021-02-18 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2021-02-23 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2021-11-22 |
| Pin, Fixation, Threaded | JDW | Class 2 | Orthopedic | No | 2016-04-13 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2024-11-27 |
| Component, Traction, Invasive | JEC | Class 2 | Orthopedic | No | 2017-08-07 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2021-07-16 |
| Nail, Fixation, Bone | JDS | Class 2 | Orthopedic | No | 2021-07-16 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite | LXT | Class 2 | Orthopedic | No | 2023-02-20 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2017-05-03 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2024-06-05 |
| Support, Patient Position | CCX | Class 1 | Anesthesiology | No | 2020-02-25 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2019-11-11 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2017-05-03 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2007-03-19 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2017-07-10 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2017-07-10 |
| Knee Arthroplasty Implantation System | OOG | Class 2 | Orthopedic | No | 2017-07-10 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2021-12-21 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Single Component | KTW | Class 2 | Orthopedic | No | 2019-10-30 |
Proprietary Names
#AR-9097-30; Retrograde Targeting Guide
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Export Device to the United States But Perform No Other Operation on Device