LOCKING COMPRESSION PLATE— 510(k) K101400

Substantially Equivalent

Changzhou Orthmed Medical Instrument Co., Ltd.

FDA 510(k) clearance K101400 for LOCKING COMPRESSION PLATE, Substantially Equivalent on 2010-11-09. Applicant: Changzhou Orthmed Medical Instrument Co., Ltd..

Clearance details

Applicant: Changzhou Orthmed Medical Instrument Co., Ltd.
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2010-05-18
Decision date: 2010-11-09
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.