FDA Registration
Active
🇺🇸 United States
ACTIFY 3D
Reg #: 3004142400
·
FEI: 3004142400
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
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
- K240669
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 |
|---|---|---|---|---|---|
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | OIY | Class 2 | Orthopedic | No | 2024-07-11 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2024-07-11 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2024-07-11 |
Proprietary Names
ACTIFY 3D
Establishment Types
Manufacture Medical Device