510(k) Report

FDA applicant

Spinemedica, LLC

Marietta, GA2 decisions2009–20090 recalls

FDA records 2 decisions for Spinemedica, LLC (Marietta, GA) in 2009: 2 510(k) clearances. All are in product code OMR (Vessel Guard Or Cover). No 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, cardiovascular panel, where it files most

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

FDA decisions per year

2in 2009

2009: 2
2009high 2 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Spinemedica, LLC by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • OMRVessel Guard Or Cover2decisions

Who builds on its devices?

Later devices cite its devices 7 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K090022Paradis Vaso ShieldSpinemedica, LLC · 20094cite it
  • K093551Paradis Vaso ShieldSpinemedica, LLC · 20093cite it

What has FDA decided for it lately?

  • K093551Paradis Vaso ShieldSpinemedica, LLC · 2009
  • K090022Paradis Vaso ShieldSpinemedica, LLC · 2009

All 2 as Spinemedica, LLC →