510(k) Report

FDA applicant

Vgi, LLC

St. Petersburg, FL1 decision2016–20161 recall

FDA records 1 decision for Vgi, LLC (St. Petersburg, FL) in 2016: 1 510(k) clearance. All are in product code OVD (Intervertebral Fusion Device With Integrated…). Its devices cite 3 predicates, 0 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Vgi, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2016: 1
2016high 1 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

1in 2018

2018: 1
2016high 1 (2018) · low 0 (2016)2026

Class I Class II/III not classified

FIG. 1 — Vgi, LLC by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K151312VerteLP Interbody Fusion DeviceVgi, LLC · 20161 recall

The one decision as Vgi, LLC →

What has been recalled?

1 recall linked to its devices; the latest:

  • K151312VGI MEDICAL VerteLP LATERAL INTERBODY FUSION instrument kitApr 9, 2018Class II