510(k) Report

FDA applicant

Trauson (Jiangsu) Medical Instrument Co., Ltd.

Shanghai, CN4 decisions2008–20090 recalls

FDA records 4 decisions for Trauson (Jiangsu) Medical Instrument Co., Ltd. (Shanghai, CN) from 2008 to 2009: 4 510(k) clearances. Most are in product codes HSB (Rod, Fixation, Intramedullary And Accessories) and HWC (Screw, Fixation, Bone). Its devices cite 5 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 Trauson (Jiangsu) Medical Instrument Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2009

2008: 22009: 2
2008high 2 (2008) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Trauson (Jiangsu) Medical Instrument Co., Ltd. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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