510(k) Report

FDA applicant

Changzhou Dean Medical Instrument Co, Ltd.

Shanghai, CN2 decisions2014–20140 recalls

FDA records 2 decisions for Changzhou Dean Medical Instrument Co, Ltd. (Shanghai, CN) in 2014: 2 510(k) clearances. Most are in product codes HRS (Plate, Fixation, Bone) and MNH (Orthosis, Spondylolisthesis Spinal Fixation). 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 Dean Medical Instrument Co, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2014

2014: 2
2014high 2 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Changzhou Dean Medical Instrument Co, Ltd. by year, 2014–2026Sources: 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
  • MNHOrthosis, Spondylolisthesis Spinal Fixation1decision

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?

  • K134011General Spinal SystemChangzhou Dean Medical Instrument Co, Ltd. · 2014
  • K133525Locking Compression Bone Plates and Screw SystemChangzhou Dean Medical Instrument Co, Ltd. · 2014

All 2 as Changzhou Dean Medical Instrument Co, Ltd. →