Data / Medical devices / United States / VGI medical, LLC
VGI medical, LLC: FDA-registered device maker in Largo, FL, United States, 2 510(k) clearances
VGI medical, LLC is registered with the FDA (registration 3006982954) in Largo, FL, United States. It lists 8 device types. The FDA files 2 510(k) clearances under its listings, the newest dated March 29, 2023. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3006982954
- Address
- 11651 87th St, Largo, FL, United States, 33773
- Owner or operator
- VGI Medical, LLC (10026541)
- Roles
- Manufacturer, Specification developer
- First device listed
- July 29, 2008
- Registered through
- 2026
- Brand names listed
- Directional Cannula, Drill Guide, Facet Distractor, Guide Wire, Implant Loading Block, Implant Holder, Implant Tamp, Positive Stop Drill Bit and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Adaptor, Holder, Syringe | IQG | 1 | Manufacturer | accessdata.fda.gov |
| Bit, Drill | HTW | 1 | Manufacturer | accessdata.fda.gov |
| Cannula, Ophthalmic | HMX | 1 | Manufacturer | accessdata.fda.gov |
| Cap, Surgical | FYF | 1 | Manufacturer | accessdata.fda.gov |
| Guide, Surgical, Instrument | FZX | 1 | Manufacturer | accessdata.fda.gov |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Sacroiliac Joint Fixation | OUR | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Tamp | HXG | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 29, 2023 | K213815 | SiJoin®T3 | OUR | Substantially Equivalent | Vgi Medical, Inc. | accessdata.fda.gov |
| January 13, 2016 | K151312 | VerteLP Interbody Fusion Device | OVD | Substantially Equivalent | Vgi, LLC | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 9, 2018 | 80012 | Class II | Terminated | VGI MEDICAL VerteLP LATERAL INTERBODY FUSION instrument kit | IFU contained an automated cleaning process for the VerteLP Instrument Tray that was not validated | accessdata.fda.gov |
Compare with other makers
- All makers of Adaptor, Holder, Syringe
- All makers of Tamp
- All makers of Cannula, Ophthalmic
- All makers of Guide, Surgical, Instrument
- All makers of Sacroiliac Joint Fixation
- All makers of Intervertebral Fusion Device With Integrated Fixation, Lumbar
Updated March 29, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.