510(k) Report

FDA applicant

Devise Ortho, Inc.

Germantown, TN1 decision2014–20140 recalls

FDA records 1 decision for Devise Ortho, Inc. (Germantown, TN) in 2014: 1 510(k) clearance. All are in product code KTT (Appliance, Fixation, Nail/Blade/Plate…). 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 Devise Ortho, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2014: 1
2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Devise Ortho, Inc. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Devise Ortho, 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 Component1decision

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.

  • K140822Drive Rail SystemDevise Ortho, Inc. · 20141cites it

What has FDA decided for it lately?

  • K140822Drive Rail SystemDevise Ortho, Inc. · 2014

The one decision as Devise Ortho, Inc. →