TRAUSON BONE SCREW, MODELS HA 3.5 AND 4.5— 510(k) K073159

Name: FDA 510(k) clearance K073159
Creator: U.S. Food and Drug Administration
Published: 2008-07-23

Substantially Equivalent

Trauson (Jiangsu) Medical Instrument Co., Ltd.

FDA 510(k) clearance K073159 for TRAUSON BONE SCREW, MODELS HA 3.5 AND 4.5, Substantially Equivalent on 2008-07-23. Applicant: Trauson (Jiangsu) Medical Instrument Co., Ltd.. Device class: 2.

Clearance details

Applicant: Trauson (Jiangsu) Medical Instrument Co., Ltd.
Product code: Code HWC
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2007-11-08
Decision date: 2008-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

Download summary PDF View on FDA.gov ↗

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More clearances from Trauson (Jiangsu) Medical Instrument Co., Ltd.

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K082617 — TRAUSON GENERAL SPINAL SYSTEM (GSS)2009-01-15
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K073432 — TRAUSON BONE PLATE2008-08-13

Adverse events under product code HWC

product code HWC

Death: 20
Injury: 15,910
Malfunction: 8,192
Other: 1
Total: 24,123

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.