510(k) Report

FDA applicant

R&B Surgical Solutions, LLC

Chesterland, OH1 decision2003–20030 recalls

FDA records 1 decision for R&B Surgical Solutions, LLC (Chesterland, OH) in 2003: 1 510(k) clearance. All are in product code KWQ (Appliance, Fixation, Spinal Intervertebral Body). 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 R&B Surgical Solutions, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for R&B Surgical Solutions, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — R&B Surgical Solutions, LLC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • KWQAppliance, Fixation, Spinal Intervertebral Body1decision

What has FDA decided for it lately?

  • K032752R&B Surgical Smartplate Cervical Plate SystemR&B Surgical Solutions, LLC · 2003

The one decision as R&B Surgical Solutions, LLC →