FDA Registration
Active
🇺🇸 United States
AVALIGN INTEGRATED MEDICAL SOLUTIONS, INC
Reg #: 1527105
·
FEI: 1000069183
·
Expires 2025
Products
5
Proprietary Names
0
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- AVALIGN INTEGRATED MEDICAL SOLUTIONS, INC
- Registration Number
- 1527105
- FEI Number
- 1000069183
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 7124 Industrial Park Blvd
- City
- Mentor
- State
- OH
- ZIP
- 44060
- Country
- US
Regulatory Submissions
- 510(k) Number
- K121619
Owner / Operator
- Firm Name
- Avalign Technologies
- Operator Number
- 10051835
- Address
- 8727 Clinton Park Drive
- City
- Fort Wayne
- State
- IN
- Postal Code
- 46825
- Country
- US
- Correspondent
- Heidi Funston
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2019-06-22 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2019-06-22 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2019-06-22 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2019-06-22 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2019-06-22 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)