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

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..

Clearance details

Applicant: Trauson (Jiangsu) Medical Instrument Co., Ltd.
Product code: Code HWC
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 ↗

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.