FDA Registration
Active
🇺🇸 United States
NuVasive Pulse System
Reg #: 1056553
·
FEI: 1000132370
·
Expires 2025
Products
9
Proprietary Names
1
Establishment Types
1
Classifications
9
Registration Details
- Registration Name
- REMINGTON MEDICAL, INC.
- Registration Number
- 1056553
- FEI Number
- 1000132370
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 6830 Meadowridge Ct
- City
- ALPHARETTA
- State
- GA
- ZIP
- 30005
- Country
- US
Regulatory Submissions
- 510(k) Number
- K210574
Owner / Operator
- Firm Name
- REMINGTON MEDICAL, INC.
- Operator Number
- 9006473
- Address
- 6830 MEADOWRIDGE CT., --
- City
- Alpharetta
- State
- GA
- Postal Code
- 30005
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electromyograph, Diagnostic | IKN | Class 2 | Physical Medicine | No | 2022-12-16 |
| Stimulator, Nerve | ETN | Class 2 | Ear, Nose, Throat | No | 2022-12-16 |
| Neurological Stereotaxic Instrument | HAW | Class 2 | Neurology | No | 2022-12-16 |
| Neurosurgical Nerve Locator | PDQ | Class 2 | Ear, Nose, Throat | No | 2022-12-16 |
| Stimulator, Electrical, Evoked Response | GWF | Class 2 | Neurology | No | 2022-12-16 |
| System, X-Ray, Fluoroscopic, Image-Intensified | JAA | Class 2 | Radiology | No | 2022-12-16 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2022-12-16 |
| Interventional Fluoroscopic X-Ray System | OWB | Class 2 | Radiology | No | 2022-12-16 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2022-12-16 |
Proprietary Names
NuVasive Pulse System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)