MICROWARE BONE PLATES AND BONE SCREWS— 510(k) K072562

Substantially Equivalent

Microware Precision Co., Ltd.

FDA 510(k) clearance K072562 for MICROWARE BONE PLATES AND BONE SCREWS, Substantially Equivalent on 2008-12-04. Applicant: Microware Precision Co., Ltd..

Clearance details

Applicant: Microware Precision Co., Ltd.
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2007-09-11
Decision date: 2008-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taichung City, TW

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.