510(k) Report

FDA applicant

Xiamen Double Engine Medical Material Co., Ltd.

Xiamen, Fujian, CN2 decisions2013–20140 recalls

FDA records 2 decisions for Xiamen Double Engine Medical Material Co., Ltd. (Xiamen, Fujian, CN) from 2013 to 2014: 2 510(k) clearances. Most are in product codes HSB (Rod, Fixation, Intramedullary And Accessories) and HRS (Plate, Fixation, Bone). Its devices cite 7 predicates, 0 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 Xiamen Double Engine Medical Material Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2013: 12014: 1
2013high 1 (2013) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Xiamen Double Engine Medical Material Co., Ltd. by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • HSBRod, Fixation, Intramedullary And Accessories1decision
  • HRSPlate, Fixation, Bone1decision

Whose devices does it build on?

Its devices cite 7 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 10 times; 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.

  • K130108Double Engine Bone Plate and Screw SystemsXiamen Double Engine Medical Material Co., Ltd. · 20139cite it
  • K131609Double Engine Intrameddullary Nail SystemXiamen Double Engine Medical Material Co., Ltd. · 20141cites it

What has FDA decided for it lately?

  • K131609Double Engine Intrameddullary Nail SystemXiamen Double Engine Medical Material Co., Ltd. · 2014
  • K130108Double Engine Bone Plate and Screw SystemsXiamen Double Engine Medical Material Co., Ltd. · 2013

All 2 as Xiamen Double Engine Medical Material Co., Ltd. →