K111432

Substantially Equivalent

EVOLVE (R) TRIAD (TM) PLATING SYSTEM AND EVOLVE (R) TRIAD (TM) BONE SCREWS

Applicant: Wrightmedicaltechnologyinc
Product code: HRS
Advisory panel: Orthopedic
Date received: 2011-05-23
Decision date: 2011-08-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington, TN, US

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.