FDA applicant

Weigao Orthopaedic Device Co., Ltd.

Shanghai, CN5 decisions2012–20140 recalls

FDA records 5 decisions for Weigao Orthopaedic Device Co., Ltd. (Shanghai, CN) from 2012 to 2014: 5 510(k) clearances. Most are in product codes MAX (Intervertebral Fusion Device With Bone Graft…) and HSB (Rod, Fixation, Intramedullary And Accessories). Its devices cite 6 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 Weigao Orthopaedic Device Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2012high 3 (2013) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Weigao Orthopaedic Device Co., Ltd. by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Weigao Orthopaedic Device Co., Ltd.’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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Weigao Orthopaedic Device Co., Ltd.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?