FDA applicant

Companion Spine France

Merignac4 decisions2009–20250 recalls

FDA records 4 decisions for Companion Spine France (Merignac) from 2009 to 2025: 1 510(k) clearance and 3 original PMA approvals. Most are in product codes NQO (Prosthesis, Spinous Process Spacer/Plate) and QLR (Manual Instruments Designed For Use With…). No recall is linked to its devices.

FDA’s records also spell it “Companion Spine France Sas”.

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 Companion Spine France’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2009high 2 (2025) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Companion Spine France by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Companion”

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

Companion Medical, Inc. 5 Companion Products Intl. 2

Companion Spine France

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Companion”