Metal Cannulated Screw— 510(k) K221090

Substantially Equivalent

Double Medical Technology, Inc.

FDA 510(k) clearance K221090 for Metal Cannulated Screw, Substantially Equivalent on 2023-01-10. Applicant: Double Medical Technology, Inc..

Clearance details

Applicant: Double Medical Technology, Inc.
Product code: Code HWC
Advisory panel: Orthopedic
Date received: 2022-04-13
Decision date: 2023-01-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Xiamen, 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.