DART-FIRE EDGE Cannulated Screw System— 510(k) K203228

Substantially Equivalent

Wright Medical

FDA 510(k) clearance K203228 for DART-FIRE EDGE Cannulated Screw System, Substantially Equivalent on 2021-05-11. Applicant: Wright Medical.

Clearance details

Applicant: Wright Medical
Product code: Code HWC
Advisory panel: Orthopedic
Date received: 2020-11-02
Decision date: 2021-05-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, US

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.