FDA Registration
Active
🇨🇳 China
CD Horizon ModuLeX Spinal System
Reg #: 3005677016
·
FEI: 3005677016
·
Expires 2025
Products
5
Proprietary Names
1
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- Medtronic (Changzhou) Medical Devices Technology Co., Ltd
- Registration Number
- 3005677016
- FEI Number
- 3005677016
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Building #3, 11 ChangJiang North Road, Xinbei District
- City
- Changzhou Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K223494
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 |
|---|---|---|---|---|---|
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | HBE | Class 2 | Neurology | No | 2023-06-19 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2023-06-19 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2023-06-19 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2023-06-19 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2023-06-19 |
Proprietary Names
CD Horizon ModuLeX Spinal System
Establishment Types
Manufacture Medical Device