510(k) K151118— Smith and Nephew Legion Hinge Knee System

Substantially Equivalent

Smith & Nephew

Clearance details

Applicant: Smith & Nephew
Product code: Code KRO
Advisory panel: Orthopedic
Date received: 2015-04-27
Decision date: 2015-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cordova, TN, US

Adverse events under product code KRO

product code KRO

Death: 19
Injury: 4,841
Total: 4,860

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.