510(k) Report

FDA applicant

Jiangsu Ideal Medical Science & Technology Co., LT

Shanghai, CN2 decisions2013–20150 recalls

FDA records 2 decisions for Jiangsu Ideal Medical Science & Technology Co., LT (Shanghai, CN) from 2013 to 2015: 2 510(k) clearances. Most are in product codes HSB (Rod, Fixation, Intramedullary And Accessories) and HRS (Plate, Fixation, Bone). Its devices cite 4 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 Ideal Medical Science & Technology Co., LT’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2013: 12015: 1
2013high 1 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Jiangsu Ideal Medical Science & Technology Co., LT by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • HSBRod, Fixation, Intramedullary And Accessories1decision
  • HRSPlate, Fixation, Bone1decision

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K141825IDEAL Locking Plate SystemJiangsu Ideal Medical Science & Technology Co., LT · 2015
  • K132428IDEALJiangsu Ideal Medical Science & Technology Co., LT · 2013

All 2 as Jiangsu Ideal Medical Science & Technology Co., LT →