FDA Registration
Active
🇺🇸 United States
ATEC Porous Ti (PTi) Thoracolumbar Spacer System
Reg #: 2027467
·
FEI: 2027467
·
Expires 2025
Products
4
Proprietary Names
3
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
- K183705
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 |
|---|---|---|---|---|---|
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2019-03-01 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2019-03-01 |
| Intervertebral Fusion Device With Bone Graft, Thoracic | PHM | Class 2 | Orthopedic | No | 2019-03-01 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2019-03-01 |
Proprietary Names
ATEC Porous Ti (PTi) Thoracolumbar Spacer System
Batalion Lumbar Spinal Spacer
IdentiTi Porous Ti Interbody System
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device