FDA applicant

Brm Extremities

Civate, IT4 decisions2020–20230 recalls

FDA records 4 decisions for Brm Extremities (Civate, IT) from 2020 to 2023: 4 510(k) clearances. Most are in product codes HWC (Screw, Fixation, Bone) and KWH (Prosthesis, Toe, Constrained, Polymer). Its devices cite 8 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Brm Extremities Srl”.

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

FDA decisions per year

1in 2023

2020high 2 (2022) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

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

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Brm Extremities

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?