510(k) Report

FDA applicant

Azurmeds, Inc.

Chicago, IL2 decisions2020–20210 recalls

FDA records 2 decisions for Azurmeds, Inc. (Chicago, IL) from 2020 to 2021: 2 510(k) clearances. All are in product code HWC (Screw, Fixation, Bone). Its devices cite 2 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 Azurmeds, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2020: 12021: 1
2020high 1 (2020) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Azurmeds, Inc. by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • HWCScrew, Fixation, Bone2decisions

Whose devices does it build on?

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

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K200987LTJ Screws and WasherAzurmeds, Inc. · 20201cites it

What has FDA decided for it lately?

  • K210268LTJ Screws and WasherAzurmeds, Inc. · 2021
  • K200987LTJ Screws and WasherAzurmeds, Inc. · 2020

All 2 as Azurmeds, Inc. →