510(k) Report

FDA applicant

Orthospin

Misgav, IL2 decisions2019–20210 recalls

FDA records 2 decisions for Orthospin (Misgav, IL) from 2019 to 2021: 2 510(k) clearances. All are in product code KTT (Appliance, Fixation, Nail/Blade/Plate…). 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 “Orthospin, Ltd.”.

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 Orthospin’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2019: 12021: 1
2019high 1 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Orthospin by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

Who builds on its devices?

Later devices cite its devices 3 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.

  • K202810AutoStrut G2Orthospin, Ltd. · 20212cite it
  • K191241AutoStrutOrthospin · 20191cites it

What has FDA decided for it lately?

  • K202810AutoStrut G2Orthospin, Ltd. · 2021
  • K191241AutoStrutOrthospin · 2019

The one decision as Orthospin →The one decision as Orthospin, Ltd. →