510(k) Report

FDA applicant

Anjon Holdings, LLC

Jacksonville, FL2 decisions2018–20201 recall

FDA records 2 decisions for Anjon Holdings, LLC (Jacksonville, FL) from 2018 to 2020: 2 510(k) clearances. All are in product code JEC (Component, Traction, Invasive). Its devices cite 5 predicates, 1 of them its own earlier devices. 1 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 Anjon Holdings, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2018: 12020: 1
2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

1in 2020

2020: 1
2018high 1 (2020) · low 0 (2018)2026

Class I Class II/III not classified

FIG. 1 — Anjon Holdings, LLC by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • JECComponent, Traction, Invasive2decisions

Whose devices does it build on?

Its devices cite 5 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.

  • K193256Anjon Bremer Halo SystemAnjon Holdings, LLC · 20202cite it
  • K171863Anjon Bremer Halo SystemAnjon Holdings, LLC · 20181cites it

What has FDA decided for it lately?

  • K193256Anjon Bremer Halo SystemAnjon Holdings, LLC · 20201 recall
  • K171863Anjon Bremer Halo SystemAnjon Holdings, LLC · 2018

All 2 as Anjon Holdings, LLC →

What has been recalled?

1 recall linked to its devices; the latest:

  • K193256Anjon Bremer Molded Crown. bone fixation fastener for spinal use. REF number 100048 -…Jun 18, 2020Class II