FDA Registration
Active
🇺🇸 United States
IntraOp Alignment System
Reg #: 2027467
·
FEI: 2027467
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
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
- K240199
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 |
|---|---|---|---|---|---|
| System, X-Ray, Fluoroscopic, Image-Intensified | JAA | Class 2 | Radiology | No | 2024-08-09 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2024-08-09 |
| Interventional Fluoroscopic X-Ray System | OWB | Class 2 | Radiology | No | 2024-08-09 |
Proprietary Names
IntraOp Alignment System
Establishment Types
Manufacture Medical Device