FDA Registration
Active
🇺🇸 United States
COLIGNE AG
Reg #: 1724670
·
FEI: 3002840549
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- NEW ROAD ENTERPRISES, INC.
- Registration Number
- 1724670
- FEI Number
- 3002840549
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 1951 33RD ST.
- City
- BOULDER
- State
- CO
- ZIP
- 80301
- Country
- US
Regulatory Submissions
- 510(k) Number
- K032604
Owner / Operator
- Firm Name
- New Road Enterprises / Young
- Operator Number
- 9039483
- Address
- 1951 33RD ST., --
- City
- Boulder
- State
- CO
- Postal Code
- 80301
- Country
- US
- Correspondent
- David - Young
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2025-02-18 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2025-02-18 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2025-02-18 |
Proprietary Names
COLIGNE AG
Establishment Types
Manufacture Medical Device