Internal Locking Plate and Screw Fixation System— 510(k) K232394

Substantially Equivalent

Changzhou Geasure Medical Apparatus and Instruments Co., Ltd.

FDA 510(k) clearance K232394 for Internal Locking Plate and Screw Fixation System, Substantially Equivalent on 2023-12-15. Applicant: Changzhou Geasure Medical Apparatus and Instruments Co., Ltd..

Clearance details

Applicant: Changzhou Geasure Medical Apparatus and Instruments Co., Ltd.
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2023-08-09
Decision date: 2023-12-15
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.