FDA Registration
Active
🇺🇸 United States
NV M5 System
Reg #: 3009144915
·
FEI: 3009144915
·
Expires 2025
Products
6
Proprietary Names
1
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- NUVASIVE, INC.
- Registration Number
- 3009144915
- FEI Number
- 3009144915
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- City View Plaza 1 Suites 116 & 117, #48 Rd 165 Km 1.2
- City
- Guaynabo
- State
- PR
- ZIP
- 00968
- Country
- US
Regulatory Submissions
- 510(k) Number
- K123307
Owner / Operator
- Firm Name
- NUVASIVE, INC.
- Operator Number
- 9036345
- Address
- 2560 General Armistead Ave, VALLEY FORGE BUSINESS CENTER
- City
- Audubon
- State
- PA
- Postal Code
- 19403
- Country
- US
- Correspondent
- Daniel S Paul
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2013-04-29 |
| Neurological Stereotaxic Instrument | HAW | Class 2 | Neurology | No | 2013-04-29 |
| Neurosurgical Nerve Locator | PDQ | Class 2 | Ear, Nose, Throat | No | 2013-04-29 |
| Electromyograph, Diagnostic | IKN | Class 2 | Physical Medicine | No | 2013-04-29 |
| Stimulator, Nerve | ETN | Class 2 | Ear, Nose, Throat | No | 2013-04-29 |
| Stimulator, Electrical, Evoked Response | GWF | Class 2 | Neurology | No | 2013-04-29 |
Proprietary Names
NV M5 System
Establishment Types
Manufacture Medical Device