510(k) Report

FDA applicant

Advanced Spine Fixation Systems, Inc.

Cypress, CA16 decisions1989–20000 recalls

FDA records 16 decisions for Advanced Spine Fixation Systems, Inc. (Cypress, CA) from 1989 to 2000: 16 510(k) clearances. Most are in product codes MNH (Orthosis, Spondylolisthesis Spinal Fixation) and KWP (Appliance, Fixation, Spinal Interlaminal). Its devices cite 1 predicate, 1 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 Fixation Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Advanced Spine Fixation Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Advanced Spine Fixation Systems, 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?

  • MNHOrthosis, Spondylolisthesis Spinal Fixation8decisions
  • KWPAppliance, Fixation, Spinal Interlaminal7decisions
  • KWQAppliance, Fixation, Spinal Intervertebral Body1decision

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • K945064Selby InstrumentationAdvanced Spine Fixation Systems, Inc. · 19951cites it
  • K954770Centra-Line Grapple, Varifix SystemAdvanced Spine Fixation Systems, Inc. · 19961cites it

What has FDA decided for it lately?

  • K992012Wiltse SystemAdvanced Spine Fixation Systems, Inc. · 2000
  • K990845Modification to Parts Numbered CGT-SL and CGT-SL-15Advanced Spine Fixation Systems, Inc. · 1999
  • K954770Centra-Line Grapple, Varifix SystemAdvanced Spine Fixation Systems, Inc. · 1996
  • K953779Saddle with Anchor, Stainless Steel Varifix SystemAdvanced Spine Fixation Systems, Inc. · 1995
  • K953778Saddle with Anchor, Titanium Varifix SystemAdvanced Spine Fixation Systems, Inc. · 1995
  • K953369Stainless Steel Varifix System 5.0MM Diameter Anchor ScrewAdvanced Spine Fixation Systems, Inc. · 1995
  • K9513085.8MM Diameter Anchor ScrewAdvanced Spine Fixation Systems, Inc. · 1995
  • K951172Titanium Low Profile Cross BarAdvanced Spine Fixation Systems, Inc. · 1995

All 16 as Advanced Spine Fixation Systems, Inc. →