FDA Registration
Active
🇺🇸 United States
REVLOK Fenestrated
Reg #: 3004142400
·
FEI: 3004142400
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- GLOBUS MEDICAL, INC.
- Registration Number
- 3004142400
- FEI Number
- 3004142400
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2560 General Armistead Ave, VALLEY FORGE BUSINESS CENTER
- City
- AUDUBON
- State
- PA
- ZIP
- 19403
- Country
- US
Regulatory Submissions
- 510(k) Number
- K110280
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 |
|---|---|---|---|---|---|
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2012-01-20 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2012-01-20 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2012-01-20 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2012-01-20 |
Proprietary Names
REVLOK Fenestrated
Establishment Types
Manufacture Medical Device