FDA Registration
Active
🇺🇸 United States
IdentiTi Porous Ti Interbody System
Reg #: 2027467
·
FEI: 2027467
·
Expires 2025
Products
3
Proprietary Names
6
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
- K222028
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 Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2023-06-07 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2023-06-07 |
| Intervertebral Fusion Device With Bone Graft, Thoracic | PHM | Class 2 | Orthopedic | No | 2023-06-07 |
Proprietary Names
IdentiTi Porous Ti Interbody System
Transcend PEEK Interbody System
Transcend NanoTec Interbody System
IdentiTi NanoTec Interbody System
IdentiTi NanoTec ALIF Standalone Interbody System
IdentiTi ALIF Standalone Interbody System
Establishment Types
Manufacture Medical Device