FDA Registration
Active
🇺🇸 United States
VGI medical, LLC
Reg #: 3006982954
·
FEI: 3006982954
·
Expires 2026
Products
8
Proprietary Names
11
Establishment Types
2
Classifications
8
Registration Details
- Registration Name
- VGI medical, LLC
- Registration Number
- 3006982954
- FEI Number
- 3006982954
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 11651 87th St
- City
- Largo
- State
- FL
- ZIP
- 33773
- Country
- US
Regulatory Submissions
- 510(k) Number
- K151312
Owner / Operator
- Firm Name
- VGI Medical, LLC
- Operator Number
- 10026541
- Address
- 11651 87th St
- City
- Largo
- State
- FL
- Postal Code
- 33773
- Country
- US
- Correspondent
- Tov Vestgaarden
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2008-07-29 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2016-01-15 |
| Tamp | HXG | Class 1 | Orthopedic | No | 2008-07-29 |
| Adaptor, Holder, Syringe | IQG | Class 1 | Physical Medicine | No | 2008-07-29 |
| Cap, Surgical | FYF | Class 1 | General, Plastic Surgery | No | 2008-07-29 |
| Cannula, Ophthalmic | HMX | Class 1 | Ophthalmic | No | 2008-07-29 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2008-07-29 |
| Sacroiliac Joint Fixation | OUR | Class 2 | Orthopedic | No | 2023-04-05 |
Proprietary Names
Facet Distractor
VerteLP
Implant Tamp
Implant Loading Block
Tapping Cap
Drill Guide
Directional Cannula
Positive Stop Drill Bit
Implant Holder
Guide Wire
SiJoin T3, SiJoin T4, SiJoin T5
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility