FDA applicant

Fusion Innovations, LLC

Maitland, FL2 decisions2022–20250 recalls

FDA records 2 decisions for Fusion Innovations, LLC (Maitland, FL) from 2022 to 2025: 2 510(k) clearances. All are in product code HRS (Plate, Fixation, Bone). Its devices cite 3 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 Fusion Innovations, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2022high 1 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Fusion Innovations, LLC by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Fusion”

FDA records each applicant name separately; these may or may not be the same firm.

Fusion Orthopedics, LLC 13 Fusion Medical Technologies, Inc. 3 Fusion Robotics, LLC 2 Fusion Orthopedics USA, LLC 1

Fusion Innovations, LLC

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?

Other applicant names beginning “Fusion”