FDA applicant

Mylad Orthopedic Solutions, LLC

Mclean, VA3 decisions2008–20110 recalls

FDA records 3 decisions for Mylad Orthopedic Solutions, LLC (Mclean, VA) from 2008 to 2011: 3 510(k) clearances. All are in product code HSB (Rod, Fixation, Intramedullary And Accessories). Its devices cite 9 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Mylad Orthopedic Solutions”.

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 Mylad Orthopedic Solutions, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2008high 1 (2008) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Mylad Orthopedic Solutions, LLC by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Mylad Orthopedic 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?