FDA Registration
Active
🇩🇪 Germany
CD Horizon Astute Spinal System
Reg #: 3011795235
·
FEI: 3011795235
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH
- Registration Number
- 3011795235
- FEI Number
- 3011795235
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- ULRICHSBERGERSTR. 17
- City
- DEGGENDORF Bavaria
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K191066
Owner / Operator
- Firm Name
- Medtronic, Inc.
- Operator Number
- 2112641
- Address
- 710 Medtronic Parkway
- City
- Minneapolis
- State
- MN
- Postal Code
- 55432
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2019-10-18 |
| Posterior Metal/Polymer Spinal System, Fusion | NQP | Class 2 | Orthopedic | No | 2019-10-18 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2019-10-18 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2019-10-18 |
Proprietary Names
CD Horizon Astute Spinal System
Establishment Types
Manufacture Medical Device