510(k) Report

FDA applicant

Saferay Spine, LLC

Westminster, CO3 decisions2012–20140 recalls

FDA records 3 decisions for Saferay Spine, LLC (Westminster, CO) from 2012 to 2014: 3 510(k) clearances. All are in product code OWB (Interventional Fluoroscopic X-Ray System). Its devices cite 4 predicates, 3 of them its own earlier devices. 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, radiology panel, where it files most

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

FDA decisions per year

1in 2014

2012: 12013: 12014: 1
2012high 1 (2012) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Saferay Spine, LLC by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • OWBInterventional Fluoroscopic X-Ray System3decisions

Whose devices does it build on?

Its devices cite 4 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 3 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.

  • K123226LessraySaferay Spine, LLC · 20122cite it
  • K142243LessRay with TrackingSaferay Spine, LLC · 20142cite it
  • K132970LessraySaferay Spine, LLC · 20131cites it

What has FDA decided for it lately?

  • K142243LessRay with TrackingSaferay Spine, LLC · 2014
  • K132970LessraySaferay Spine, LLC · 2013
  • K123226LessraySaferay Spine, LLC · 2012

All 3 as Saferay Spine, LLC →