FDA Registration
Active
🇺🇸 United States
Arsenal Spinal Fixation System
Reg #: 2027467
·
FEI: 2027467
·
Expires 2025
Products
4
Proprietary Names
2
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- ALPHATEC SPINE, INC.
- Registration Number
- 2027467
- FEI Number
- 2027467
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 1950 Camino Vida Roble
- City
- Carlsbad
- State
- CA
- ZIP
- 92008
- Country
- US
Regulatory Submissions
- 510(k) Number
- K133221
Owner / Operator
- Firm Name
- ALPHATEC HOLDINGS, INC.
- Operator Number
- 9072657
- Address
- 1950 Camino Vida Roble
- City
- Carlsbad
- State
- CA
- Postal Code
- 92008
- Country
- US
- Correspondent
- Brian - Beireis
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2014-03-25 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2014-03-25 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2014-03-25 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2014-03-25 |
Proprietary Names
Arsenal Spinal Fixation System
Arsenal Spinal Fixation System, Degenerative
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device