FDA Registration
Active
🇺🇸 United States
HEDRON
Reg #: 3004142400
·
FEI: 3004142400
·
Expires 2025
Products
6
Proprietary Names
2
Establishment Types
1
Classifications
6
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
- K222270
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 |
|---|---|---|---|---|---|
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2022-11-28 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2022-11-28 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2022-11-28 |
| Intervertebral Fusion Device With Bone Graft, Thoracic | PHM | Class 2 | Orthopedic | No | 2022-11-28 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2022-11-28 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2022-11-28 |
Proprietary Names
HEDRON
SABLE
Establishment Types
Manufacture Medical Device