FDA applicant

Fusion Orthopedics USA, LLC

Mesa, AZ1 decision2026–20260 recalls

FDA records 1 decision for Fusion Orthopedics USA, LLC (Mesa, AZ) in 2026: 1 510(k) clearance. All are in product code HSB (Rod, Fixation, Intramedullary And Accessories). Its devices cite 2 predicates, 0 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 Orthopedics USA, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2026

2026high 1 (2026)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2026.

FIG. 1 — Fusion Orthopedics USA, LLC by year, 2026–2026Sources: 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 Innovations, LLC 2 Fusion Robotics, LLC 2

Fusion Orthopedics USA, LLC

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Fusion”