FDA Registration
Active
🇺🇸 United States
Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal Fixation Systems: (Firebird Def
Reg #: 2183449
·
FEI: 2183449
·
Expires 2025
Products
5
Proprietary Names
1
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- ORTHOFIX US LLC
- Registration Number
- 2183449
- FEI Number
- 2183449
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 3451 Plano Parkway
- City
- Lewisville
- State
- TX
- ZIP
- 75056
- Country
- US
Regulatory Submissions
- 510(k) Number
- K211710
Owner / Operator
- Firm Name
- Orthofix US LLC
- Operator Number
- 10028162
- Address
- 3451 Plano Parkway
- City
- Lewisville
- State
- TX
- Postal Code
- 75056
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2021-08-11 |
| Posterior Cervical Screw System | NKG | Class 2 | Orthopedic | No | 2021-08-11 |
| Sacroiliac Joint Fixation | OUR | Class 2 | Orthopedic | No | 2021-08-11 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2021-08-11 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2021-08-11 |
Proprietary Names
Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal Fixation Systems: (Firebird Def
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility