Locking Plate System— 510(k) K162380

Substantially Equivalent

Beijing Keyi Medical Device Technology Co., Ltd.

FDA 510(k) clearance K162380 for Locking Plate System, Substantially Equivalent on 2017-05-02. Applicant: Beijing Keyi Medical Device Technology Co., Ltd..

Clearance details

Applicant: Beijing Keyi Medical Device Technology Co., Ltd.
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2016-08-24
Decision date: 2017-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beijing, 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.