510(k) Report

FDA applicant

Extraortho, Inc.

Alexandria, VA2 decisions2011–20120 recalls

FDA records 2 decisions for Extraortho, Inc. (Alexandria, VA) from 2011 to 2012: 2 510(k) clearances. All are in product code KTT (Appliance, Fixation, Nail/Blade/Plate…). Its devices cite 8 predicates, 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 Extraortho, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2011: 12012: 1
2011high 1 (2011) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Extraortho, Inc. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Extraortho, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component2decisions

Whose devices does it build on?

Its devices cite 8 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 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.

  • K113383Xtrafix External Fixation SystemExtraortho, Inc. · 20125cite it
  • K111155Xtrafix External Fixation SystemExtraortho, Inc. · 20111cites it

What has FDA decided for it lately?

  • K113383Xtrafix External Fixation SystemExtraortho, Inc. · 2012
  • K111155Xtrafix External Fixation SystemExtraortho, Inc. · 2011

All 2 as Extraortho, Inc. →