510(k) Report

FDA applicant

Changzhou Dingjian Medical Appliance Co., Ltd.

Changzhou, CN2 decisions2015–20150 recalls

FDA records 2 decisions for Changzhou Dingjian Medical Appliance Co., Ltd. (Changzhou, CN) in 2015: 2 510(k) clearances. Most are in product codes MNH (Orthosis, Spondylolisthesis Spinal Fixation) and HRS (Plate, Fixation, Bone). 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 Changzhou Dingjian Medical Appliance Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2015

2015: 2
2015high 2 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Changzhou Dingjian Medical Appliance Co., Ltd. by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Changzhou Dingjian Medical Appliance…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • MNHOrthosis, Spondylolisthesis Spinal Fixation1decision
  • HRSPlate, Fixation, Bone1decision

Whose devices does it build on?

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

Who builds on its devices?

Later devices cite its devices 2 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.

  • K143013Spinal Inner Fixation SystemChangzhou Dingjian Medical Appliance Co., Ltd. · 20151cites it
  • K143002Metallic Locking Bone Plate and Screw SystemChangzhou Dingjian Medical Appliance Co., Ltd. · 20151cites it

What has FDA decided for it lately?

  • K143013Spinal Inner Fixation SystemChangzhou Dingjian Medical Appliance Co., Ltd. · 2015
  • K143002Metallic Locking Bone Plate and Screw SystemChangzhou Dingjian Medical Appliance Co., Ltd. · 2015

All 2 as Changzhou Dingjian Medical Appliance Co., Ltd. →