510(k) Report

FDA applicant

Esm Technologies, LLC

Madison, WI2 decisions2005–20070 recalls

FDA records 2 decisions for Esm Technologies, LLC (Madison, WI) from 2005 to 2007: 2 510(k) clearances. All are in product code KWQ (Appliance, Fixation, Spinal Intervertebral Body). Its devices cite 2 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Esm Technologies”.

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 Esm Technologies, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Esm 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 Body2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K051764T-Plate Anterior Fixation SystemEsm Technologies · 20051cites it

What has FDA decided for it lately?

  • K072231The Translation Plate Phase 1 (T-1 Plate) and Phase 2 (T-2 Plate)Esm Technologies, LLC · 2007
  • K051764T-Plate Anterior Fixation SystemEsm Technologies · 2005

The one decision as Esm Technologies, LLC →The one decision as Esm Technologies →