FDA applicant

Spineguard S.A.

Vincennes, FR7 decisions2013–20240 recalls

FDA records 7 decisions for Spineguard S.A. (Vincennes, FR) from 2013 to 2024: 7 510(k) clearances. Most are in product codes PDQ (Neurosurgical Nerve Locator) and HBG (Drills, Burrs, Trephines & Accessories (Manual)). Its devices cite 9 predicates, 6 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Spineguard”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, ear, nose and throat panel, where it files most

How often FDA has decided Spineguard S.A.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2013high 1 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Spineguard S.A. by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Spineguard S.A.’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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Spineguard S.A.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?