510(k) Report

FDA applicant

Alphaspine, Inc.

American Fork, UT1 decision2006–20060 recalls

FDA records 1 decision for Alphaspine, Inc. (American Fork, UT) in 2006: 1 510(k) clearance. All are in product code KWQ (Appliance, Fixation, Spinal Intervertebral Body). 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 Alphaspine, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Alphaspine, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Alphaspine, Inc. 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

Who builds on its devices?

Later devices cite its devices 2 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.

  • K062371Preview Anterior Cervical Plate SystemAlphaspine, Inc. · 20062cite it

What has FDA decided for it lately?

  • K062371Preview Anterior Cervical Plate SystemAlphaspine, Inc. · 2006

The one decision as Alphaspine, Inc. →