FDA Registration
Active
🇺🇸 United States
Deformity Correxxion
Reg #: 3007922509
·
FEI: 3007922509
·
Expires 2025
Products
5
Proprietary Names
1
Establishment Types
2
Classifications
5
Registration Details
- Registration Name
- NEXXT SPINE LLC
- Registration Number
- 3007922509
- FEI Number
- 3007922509
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 14425 Bergen Blvd Suite B
- City
- Noblesville
- State
- IN
- ZIP
- 46060
- Country
- US
Regulatory Submissions
- 510(k) Number
- K153453
Owner / Operator
- Firm Name
- Nexxt Spine LLC
- Operator Number
- 10030542
- Address
- 14425 Bergen Blvd Suite B
- City
- Noblesville
- State
- IN
- Postal Code
- 46060
- Country
- US
- Correspondent
- Andrew Elsbury
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2016-04-27 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2016-04-27 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2016-04-27 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2016-04-27 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2016-04-27 |
Proprietary Names
Deformity Correxxion
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device