FDA Registration
Active
🇺🇸 United States
AVALIGN INTEGRATED MEDICAL SOLUTIONS, INC
Reg #: 1527105
·
FEI: 1000069183
·
Expires 2026
Products
15
Proprietary Names
2
Establishment Types
1
Classifications
15
Registration Details
- Registration Name
- AVALIGN INTEGRATED MEDICAL SOLUTIONS, INC
- Registration Number
- 1527105
- FEI Number
- 1000069183
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 7124 Industrial Park Blvd
- City
- Mentor
- State
- OH
- ZIP
- 44060
- Country
- US
Owner / Operator
- Firm Name
- Avalign Technologies
- Operator Number
- 10051835
- Address
- 110275 W. Higgins Rd, Suite 920
- City
- Rosemont
- State
- IL
- Postal Code
- 60018
- Country
- US
- Correspondent
- Heidi Funston
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2019-06-22 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2019-06-22 |
| Orthosis, Spinal Pedicle Fixation | MNI | 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 |
| Posterior Cervical Screw System | NKG | Class 2 | Orthopedic | No | 2026-01-30 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2023-11-15 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2023-11-15 |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2019-06-22 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2019-06-22 |
| Plate, Bone, Growth Control, Pediatric, Epiphysiodesis | OBT | Class 2 | Orthopedic | No | 2019-06-22 |
| Orthosis, Cervical | IQK | Class 1 | Physical Medicine | No | 2019-06-22 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2025-07-25 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2025-07-25 |
| Bone Fixation Cerclage, Sublaminar | OWI | Class 2 | Orthopedic | No | 2026-01-30 |
Proprietary Names
Mini Polyaxial Bone Screw
GUIDED GROWTH SYSTEM EIGHT-PLATE, QUAD-PLATE (STAINLESS STEEL)
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)