LOCKING BONE SCREW MODEL HCQ04, HCZ04— 510(k) K100721

Substantially Equivalent

Changzhou Orthmar Medical Instrument Co., Ltd.

FDA 510(k) clearance K100721 for LOCKING BONE SCREW MODEL HCQ04, HCZ04, Substantially Equivalent on 2010-11-23. Applicant: Changzhou Orthmar Medical Instrument Co., Ltd..

Clearance details

Applicant: Changzhou Orthmar Medical Instrument Co., Ltd.
Product code: Code HWC
Advisory panel: Orthopedic
Date received: 2010-03-15
Decision date: 2010-11-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code HWC

product code HWC

Death: 20
Injury: 15,910
Malfunction: 8,192
Other: 1
Total: 24,123

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.