510(k) Report

FDA applicant

Co-Ligne AG

Concord, CA4 decisions2004–20090 recalls

FDA records 4 decisions for Co-Ligne AG (Concord, CA) from 2004 to 2009: 4 510(k) clearances. Most are in product codes MNH (Orthosis, Spondylolisthesis Spinal Fixation) and MQP (Spinal Vertebral Body Replacement Device). Its devices cite 11 predicates, 3 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 Co-Ligne AG’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2008: 12009: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Co-Ligne AG by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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