FDA Registration
Active
🇺🇸 United States
SafeOp 3 System
Reg #: 3019878714
·
FEI: 3019878714
·
Expires 2025
Products
6
Proprietary Names
1
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- Alphatec Spine, Inc.
- Registration Number
- 3019878714
- FEI Number
- 3019878714
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 4101 Willow Lake Blvd.
- City
- Memphis
- State
- TN
- ZIP
- 38118
- Country
- US
Regulatory Submissions
- 510(k) Number
- K234092
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 |
|---|---|---|---|---|---|
| Electrode, Cutaneous | GXY | Class 2 | Neurology | No | 2024-05-06 |
| Electrode, Needle | GXZ | Class 2 | Neurology | No | 2024-05-06 |
| Stimulator, Nerve | ETN | Class 2 | Ear, Nose, Throat | No | 2024-05-06 |
| Neurosurgical Nerve Locator | PDQ | Class 2 | Ear, Nose, Throat | No | 2024-05-06 |
| Stimulator, Electrical, Evoked Response | GWF | Class 2 | Neurology | No | 2024-05-06 |
| Electromyograph, Diagnostic | IKN | Class 2 | Physical Medicine | No | 2024-05-06 |
Proprietary Names
SafeOp 3 System
Establishment Types
Manufacture Medical Device