RECONSTRUCTION LOCKING PLATE AND 3.5MM LOCKING SCREW— 510(k) K112819

Substantially Equivalent

Xiamen Double Engline Medical Material Co., Ltd.

FDA 510(k) clearance K112819 for RECONSTRUCTION LOCKING PLATE AND 3.5MM LOCKING SCREW, Substantially Equivalent on 2011-12-16. Applicant: Xiamen Double Engline Medical Material Co., Ltd..

Clearance details

Applicant: Xiamen Double Engline Medical Material Co., Ltd.
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2011-09-28
Decision date: 2011-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, 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.