FDA Registration
Active
🇺🇸 United States
Avalign Delivery Systems does not manufacture thoracolumbosacral pedicle screw system. The listing has been made
Reg #: 1835444
·
FEI: 3000717687
·
Expires 2025
Products
6
Proprietary Names
2
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- Avalign Delivery Systems Division
- Registration Number
- 1835444
- FEI Number
- 3000717687
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2121 SOUTHTECH DRIVE, SUITE 600
- City
- Greenwood
- State
- IN
- ZIP
- 46143
- Country
- US
Regulatory Submissions
- 510(k) Number
- K152248
Owner / Operator
- Firm Name
- Avalign Delivery Systems Division
- Operator Number
- 9026184
- Address
- 2121 Southtech Drive, Suite 600
- City
- Greenwood
- State
- IN
- Postal Code
- 46143
- Country
- US
- Correspondent
- Thomas Clyne
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2023-09-18 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2023-09-18 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2023-09-18 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2023-09-18 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2023-09-18 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2023-09-18 |
Proprietary Names
Avalign Delivery Systems does not manufacture thoracolumbosacral pedicle screw system. The listing has been made
because Medtronic cases and trays are registered as accessories to the thoracolumbosacral pedicle screw system in K15228
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)