FDA Registration
Active
🇺🇸 United States
NuVasive NVM5 System
Reg #: 2133772
·
FEI: 3000209794
·
Expires 2025
Products
6
Proprietary Names
1
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- Spartronics Watertown LLC
- Registration Number
- 2133772
- FEI Number
- 3000209794
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2920 KELLY AVE
- City
- Watertown
- State
- SD
- ZIP
- 57201
- Country
- US
Regulatory Submissions
- 510(k) Number
- K123307
Owner / Operator
- Firm Name
- Spartronics Watertown LLC
- Operator Number
- 10045726
- Address
- 2920 Kelly Avenue, PO Box 430
- City
- Watertown
- State
- SD
- Postal Code
- 57201
- Country
- US
- Correspondent
- Evan McConnell
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Neurosurgical Nerve Locator | PDQ | Class 2 | Ear, Nose, Throat | No | 2021-07-14 |
| Electromyograph, Diagnostic | IKN | Class 2 | Physical Medicine | No | 2021-07-14 |
| Stimulator, Electrical, Evoked Response | GWF | Class 2 | Neurology | No | 2021-07-14 |
| Stimulator, Nerve | ETN | Class 2 | Ear, Nose, Throat | No | 2021-07-14 |
| Neurological Stereotaxic Instrument | HAW | Class 2 | Neurology | No | 2021-07-14 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2021-07-14 |
Proprietary Names
NuVasive NVM5 System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)