510(k) Report

FDA applicant

Smisson-Cartledge

Irvine, CA1 decision2003–20030 recalls

FDA records 1 decision for Smisson-Cartledge (Irvine, CA) in 2003: 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 Smisson-Cartledge’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Smisson-Cartledge since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Smisson-Cartledge 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 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.

  • K021979Smisson Stabilization SystemSmisson-Cartledge · 20031cites it

What has FDA decided for it lately?

  • K021979Smisson Stabilization SystemSmisson-Cartledge · 2003

The one decision as Smisson-Cartledge →

Other applicant names beginning “Smisson-Cartledge”

FDA records each applicant name separately; these may or may not be the same firm.

Smisson-Cartledge Biomedical, LLC 2