510(k) Report

FDA applicant

Jurgan Development & Mfg., Ltd.

Walker, MI1 decision1983–19830 recalls

FDA records 1 decision for Jurgan Development & Mfg., Ltd. (Walker, MI) in 1983: 1 510(k) clearance. All are in product code LYT (Fixation Accessory). 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 Jurgan Development & Mfg., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Jurgan Development & Mfg., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Jurgan Development & Mfg., Ltd. 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?

  • LYTFixation Accessory1decision

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.

  • K831072Jurgan Pin BallJurgan Development & Mfg., Ltd. · 19831cites it

What has FDA decided for it lately?

  • K831072Jurgan Pin BallJurgan Development & Mfg., Ltd. · 1983

The one decision as Jurgan Development & Mfg., Ltd. →