510(k) Report

FDA applicant

Magly Orthopedics, LLC

Woodinville, WA3 decisions2002–20020 recalls

FDA records 3 decisions for Magly Orthopedics, LLC (Woodinville, WA) in 2002: 3 510(k) clearances. Most are in product codes HWC (Screw, Fixation, Bone) and HSB (Rod, Fixation, Intramedullary And Accessories). 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 Magly Orthopedics, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Magly Orthopedics, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Magly Orthopedics, 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?

  • HWCScrew, Fixation, Bone2decisions
  • HSBRod, Fixation, Intramedullary And Accessories1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K021662Magly 6.5MM Cannulated ScrewsMagly Orthopedics, LLC · 20021cites it

What has FDA decided for it lately?

  • K021662Magly 6.5MM Cannulated ScrewsMagly Orthopedics, LLC · 2002
  • K021579Magly 4.0 and 5.5 MM Locking SystemMagly Orthopedics, LLC · 2002
  • K020562Apex Intramedullary Nail SystemMagly Orthopedics, LLC · 2002

All 3 as Magly Orthopedics, LLC →