FDA applicant

Signus Medical, LLC

Minneapolis, MN8 decisions2002–20090 recalls

FDA records 8 decisions for Signus Medical, LLC (Minneapolis, MN) from 2002 to 2009: 8 510(k) clearances. Most are in product codes MQP (Spinal Vertebral Body Replacement Device) and NKB (Thoracolumbosacral Pedicle Screw System). Its devices cite 18 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Signus Medical”.

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 Signus Medical, LLC’s devices, and how often a recall has named them.

FDA decisions per year

2in 2009

2007high 2 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Signus Medical, LLC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Other applicant names beginning “Signus”

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

Signus Medizintechnik GmbH 24 Signus Medinzintechnik GmbH 1

Signus Medical, LLC

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?

Other applicant names beginning “Signus”