FDA Registration
Active
🇺🇸 United States
CD HORIZON® Spinal System
Reg #: 3014252644
·
FEI: 3014252644
·
Expires 2025
Products
6
Proprietary Names
1
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- C&A Tool Engineering, Inc. Auburn Plant
- Registration Number
- 3014252644
- FEI Number
- 3014252644
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1015 W 15th St
- City
- Auburn
- State
- IN
- ZIP
- 46706
- Country
- US
Regulatory Submissions
- 510(k) Number
- K113174
Owner / Operator
- Firm Name
- MinebeaMitsumi Inc.
- Operator Number
- 10055758
- Address
- 3-9-6 Mita
- City
- Minato-ku
- State
- Tokyo
- Postal Code
- 108-8330
- Country
- JP
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2023-09-29 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2023-09-29 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2023-09-29 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2023-09-29 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2023-09-29 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2023-09-29 |
Proprietary Names
CD HORIZON® Spinal System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)