510(k) Report

FDA applicant

Jiangsu Trauhui Medical Instrument Co., Ltd.

Changzhou, CN2 decisions2018–20200 recalls

FDA records 2 decisions for Jiangsu Trauhui Medical Instrument Co., Ltd. (Changzhou, CN) from 2018 to 2020: 2 510(k) clearances. Most are in product codes HRS (Plate, Fixation, Bone) and NKB (Thoracolumbosacral Pedicle Screw System). Its devices cite 3 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 Jiangsu Trauhui Medical Instrument Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2018: 12020: 1
2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Jiangsu Trauhui Medical Instrument Co., Ltd. by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • HRSPlate, Fixation, Bone1decision
  • NKBThoracolumbosacral Pedicle Screw System1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K190842Comus Locking Plate systemsJiangsu Trauhui Medical Instrument Co., Ltd. · 2020
  • K172826Cellent Spinal SystemsJiangsu Trauhui Medical Instrument Co., Ltd. · 2018

All 2 as Jiangsu Trauhui Medical Instrument Co., Ltd. →