510(k) Report

FDA applicant

Advanced Spine Technology, Inc.

Oakland, CA4 decisions1995–20060 recalls

FDA records 4 decisions for Advanced Spine Technology, Inc. (Oakland, CA) from 1995 to 2006: 4 510(k) clearances. Most are in product codes KWQ (Appliance, Fixation, Spinal Intervertebral Body) and MNI (Orthosis, Spinal Pedicle Fixation). Its devices cite 1 predicate, 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 Advanced Spine Technology, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Advanced Spine Technology, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Advanced Spine Technology, 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 Body2decisions
  • MNIOrthosis, Spinal Pedicle Fixation1decision
  • MNHOrthosis, Spondylolisthesis Spinal Fixation1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 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.

  • K992147Triple-Fix Spinal Fixation SystemAdvanced Spine Technology, Inc. · 20003cite it
  • K993066Window Cervical Dynamic Plate SystemAdvanced Spine Technology, Inc. · 20001cites it

What has FDA decided for it lately?

  • K062686Universal Spinal Anterior Locking Plate SystemAdvanced Spine Technology, Inc. · 2006
  • K993066Window Cervical Dynamic Plate SystemAdvanced Spine Technology, Inc. · 2000
  • K992147Triple-Fix Spinal Fixation SystemAdvanced Spine Technology, Inc. · 2000
  • K951266Amset R-F SystemAdvanced Spine Technology, Inc. · 1995

All 4 as Advanced Spine Technology, Inc. →