510(k) Report

FDA applicant

Changzhou Geasure Medical Apparatus and Instruments Co., Ltd.

Changzhou, CN4 decisions2022–20230 recalls

FDA records 4 decisions for Changzhou Geasure Medical Apparatus and Instruments Co., Ltd. (Changzhou, CN) from 2022 to 2023: 4 510(k) clearances. Most are in product codes MAX (Intervertebral Fusion Device With Bone Graft…) and NKB (Thoracolumbosacral Pedicle Screw System). Since 2016 its 510(k)s took a median of 119 days from receipt to decision, against 104 for FDA’s reviews in the same codes and years. Its devices cite 13 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 Geasure Medical Apparatus and Instruments Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2023

2022: 12023: 3
2022high 3 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Changzhou Geasure Medical Apparatus and Instruments Co.… by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MAXIntervertebral Fusion Device With Bone Graft, Lumbar1decision
  • NKBThoracolumbosacral Pedicle Screw System1decision
  • HRSPlate, Fixation, Bone1decision
  • HSBRod, Fixation, Intramedullary And Accessories1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 119 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 104 days; 2 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 13 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K232394Internal Locking Plate and Screw Fixation SystemChangzhou Geasure Medical Apparatus and Instruments Co., Ltd. · 2023
  • K230456SGM Femoral Nail SystemChangzhou Geasure Medical Apparatus and Instruments Co., Ltd. · 2023
  • K223776PEEK Spinal Infusion CageChangzhou Geasure Medical Apparatus and Instruments Co., Ltd. · 2023
  • K222031Spinal Inner Fixation SystemChangzhou Geasure Medical Apparatus and Instruments Co., Ltd. · 2022

All 4 as Changzhou Geasure Medical Apparatus and Instruments Co., Ltd. →