Smith & Nephew ACCORD Cable System— 510(k) K223762

Substantially Equivalent

Smith & Nephew

FDA 510(k) clearance K223762 for Smith & Nephew ACCORD Cable System, Substantially Equivalent on 2023-05-30. Applicant: Smith & Nephew.

Clearance details

Applicant: Smith & Nephew
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2022-12-15
Decision date: 2023-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cordova, TN, US

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.