FDA Registration
Active
🇳🇱 Netherlands
CD Perc Trauma
Reg #: 3002807561
·
FEI: 3002807561
·
Expires 2025
Products
6
Proprietary Names
1
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- MEDTRONIC B.V. (EOC)
- Registration Number
- 3002807561
- FEI Number
- 3002807561
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- EARL BAKKENSTRAAT 10
- City
- HEERLEN Limburg
- Country
- NL
Regulatory Submissions
- 510(k) Number
- K052747
Owner / Operator
- Firm Name
- Medtronic, Inc.
- Operator Number
- 2112641
- Address
- 710 Medtronic Parkway
- City
- Minneapolis
- State
- MN
- Postal Code
- 55432
- Country
- US
US Agent
- Business Name
- Medtronic Sofamor Danek USA, Inc. (Pyramid Place)
- Contact Name
- Michelle Obenauer
- Address
- 1800 Pyramid Place
- City
- Memphis
- State
- TN
- ZIP
- 38132
- Country
- US
- [email protected]
- Phone
- 901 3992117
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2008-01-31 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2008-01-31 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2008-01-31 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2008-01-31 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2008-01-31 |
| Posterior Metal/Polymer Spinal System, Fusion | NQP | Class 2 | Orthopedic | No | 2008-01-31 |
Proprietary Names
CD Perc Trauma
Establishment Types
Export Device to the United States But Perform No Other Operation on Device