Metallic Locking Bone Plate and Screw System— 510(k) K143002

Substantially Equivalent

Changzhou Dingjian Medical Appliance Co., Ltd.

FDA 510(k) clearance K143002 for Metallic Locking Bone Plate and Screw System, Substantially Equivalent on 2015-06-05. Applicant: Changzhou Dingjian Medical Appliance Co., Ltd..

Clearance details

Applicant: Changzhou Dingjian Medical Appliance Co., Ltd.
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2014-10-20
Decision date: 2015-06-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Changzhou, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

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.