FDA Registration
Active
🇺🇸 United States
Remi Robotic Navigation System
Reg #: 3015537048
·
FEI: 3015537048
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ALPHATEC SPINE, INC.
- Registration Number
- 3015537048
- FEI Number
- 3015537048
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 168 Centennial Parkway, Unit 170
- City
- Louisville
- State
- CO
- ZIP
- 80027
- Country
- US
Regulatory Submissions
- 510(k) Number
- K223070
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 |
|---|---|---|---|---|---|
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2023-05-12 |
Proprietary Names
Remi Robotic Navigation System
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility