510(k) Report

FDA applicant

Valorus Spine

Danville, CA2 decisions2017–20180 recalls

FDA records 2 decisions for Valorus Spine (Danville, CA) from 2017 to 2018: 2 510(k) clearances. Most are in product codes KWQ (Appliance, Fixation, Spinal Intervertebral Body) and NKB (Thoracolumbosacral Pedicle Screw System). Its devices cite 6 predicates, 0 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, orthopedic panel, where it files most

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

FDA decisions per year

1in 2018

2017: 12018: 1
2017high 1 (2017) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Valorus Spine by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • KWQAppliance, Fixation, Spinal Intervertebral Body1decision
  • NKBThoracolumbosacral Pedicle Screw System1decision

Whose devices does it build on?

Its devices cite 6 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K180324Patriot Spinal Fixation SystemValorus Spine · 2018
  • K172585Liberty Anterior Cervical PlateValorus Spine · 2017

All 2 as Valorus Spine →