FDA Registration
Active
🇺🇸 United States
PULSE
Reg #: 3030412764
·
FEI: 3030412764
·
Expires 2025
Products
9
Proprietary Names
1
Establishment Types
1
Classifications
9
Registration Details
- Registration Name
- GLOBUS MEDICAL, INC.
- Registration Number
- 3030412764
- FEI Number
- 3030412764
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 4670 E. SHELBY DR
- City
- Memphis
- State
- TN
- ZIP
- 38118
- Country
- US
Regulatory Submissions
- 510(k) Number
- K180038
Owner / Operator
- Firm Name
- GLOBUS MEDICAL, INC.
- Operator Number
- 9056090
- 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 |
|---|---|---|---|---|---|
| System, X-Ray, Fluoroscopic, Image-Intensified | JAA | Class 2 | Radiology | No | 2024-02-02 |
| Neurological Stereotaxic Instrument | HAW | Class 2 | Neurology | No | 2024-02-02 |
| Stimulator, Nerve | ETN | Class 2 | Ear, Nose, Throat | No | 2024-02-02 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2024-02-02 |
| Interventional Fluoroscopic X-Ray System | OWB | Class 2 | Radiology | No | 2024-02-02 |
| Electromyograph, Diagnostic | IKN | Class 2 | Physical Medicine | No | 2024-02-02 |
| Stimulator, Electrical, Evoked Response | GWF | Class 2 | Neurology | No | 2024-02-02 |
| Neurosurgical Nerve Locator | PDQ | Class 2 | Ear, Nose, Throat | No | 2024-02-02 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2024-02-02 |
Proprietary Names
PULSE
Establishment Types
Manufacture Medical Device