FDA applicant

Biofusion Medical

Austin, TX2 decisions2019–20200 recalls

FDA records 2 decisions for Biofusion Medical (Austin, TX) from 2019 to 2020: 2 510(k) clearances. All are in product code OUR (Sacroiliac Joint Fixation). 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 Biofusion Medical’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2019high 1 (2019) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

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

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Biofusion Medical

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?