510(k) Report

FDA applicant

Us Spinal Technologies, LLC

Stillwater, MN2 decisions2004–20050 recalls

FDA records 2 decisions for Us Spinal Technologies, LLC (Stillwater, MN) from 2004 to 2005: 2 510(k) clearances. Most are in product codes KWQ (Appliance, Fixation, Spinal Intervertebral Body) and MQP (Spinal Vertebral Body Replacement Device). Its devices cite 3 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 Us Spinal Technologies, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Us Spinal Technologies, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Us Spinal Technologies, LLC by year, 2007–2026Sources: 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
  • MQPSpinal Vertebral Body Replacement Device1decision

Whose devices does it build on?

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

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K041625LTD Polyaxial Fixation SystemUs Spinal Technologies, LLC · 20041cites it

What has FDA decided for it lately?

  • K041798Atalia Titanium Surgical MeshUs Spinal Technologies, LLC · 2005
  • K041625LTD Polyaxial Fixation SystemUs Spinal Technologies, LLC · 2004

All 2 as Us Spinal Technologies, LLC →