FDA applicant

Suspension Orthopaedic Solutions, LLC

Shelton, CT4 decisions2010–20120 recalls

FDA records 4 decisions for Suspension Orthopaedic Solutions, LLC (Shelton, CT) from 2010 to 2012: 4 510(k) clearances. Most are in product codes HRS (Plate, Fixation, Bone) and JDR (Staple, Fixation, Bone). Its devices cite 7 predicates, 2 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 Suspension Orthopaedic Solutions, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2010high 2 (2010) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Suspension Orthopaedic Solutions, LLC by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Suspension Orthopaedic Solutions, 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

Suspension Orthopaedic Solutions, LLC

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?