510(k) Report

FDA applicant

Changzhou Orthmed Medical Instrument Co., Ltd.

Shanghai, CN2 decisions2010–20110 recalls

FDA records 2 decisions for Changzhou Orthmed Medical Instrument Co., Ltd. (Shanghai, CN) from 2010 to 2011: 2 510(k) clearances. Most are in product codes MNH (Orthosis, Spondylolisthesis Spinal Fixation) and HRS (Plate, Fixation, Bone). Its devices cite 1 predicate, 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 Orthmed Medical Instrument Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2010: 12011: 1
2010high 1 (2010) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Changzhou Orthmed Medical Instrument Co., Ltd. by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

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

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 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.

  • K101400Locking Compression PlateChangzhou Orthmed Medical Instrument Co., Ltd. · 20106cite it
  • K111690Devine Spinal SystemChangzhou Orthmed Medical Instrument Co., Ltd. · 20112cite it

What has FDA decided for it lately?

  • K111690Devine Spinal SystemChangzhou Orthmed Medical Instrument Co., Ltd. · 2011
  • K101400Locking Compression PlateChangzhou Orthmed Medical Instrument Co., Ltd. · 2010

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