FDA Registration
Active
🇺🇸 United States
Excelsius3D
Reg #: 3011713200
·
FEI: 3011713200
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- GLOBUS MEDICAL, INC.
- Registration Number
- 3011713200
- FEI Number
- 3011713200
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 300 GRIFFIN BROOK DRIVE
- City
- Methuen
- State
- MA
- ZIP
- 01844
- Country
- US
Regulatory Submissions
- 510(k) Number
- K210912
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 | 2021-08-31 |
| Image-Intensified Fluoroscopic X-Ray System, Mobile | OXO | Class 2 | Radiology | No | 2021-08-31 |
| Interventional Fluoroscopic X-Ray System | OWB | Class 2 | Radiology | No | 2021-08-31 |
Proprietary Names
Excelsius3D
Establishment Types
Manufacture Medical Device