FDA applicant

Axon Spine Medical System

Pompei, IT1 decision2023–20230 recalls

FDA records 1 decision for Axon Spine Medical System (Pompei, IT) in 2023: 1 510(k) clearance. All are in product code GEI (Electrosurgical, Cutting & Coagulation &…). 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, general and plastic surgery panel, where it files most

How often FDA has decided Axon Spine Medical System’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2023high 1 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Axon Spine Medical System by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Axon Spine Medical System’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Axon”

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

Axon Systems, Inc. 15 Axon Instruments, Inc. 3 Axon Medical 2 Axon Medical Technologies Corp. 1

Axon Spine Medical System

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Axon”