FDA applicant
Trauson (Jiangsu) Medical Instrument Co., Ltd.
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
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
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2008.
Planning a device like Trauson (Jiangsu) Medical Instrument…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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