K050492

Substantially Equivalent

INTEGRA BONE FIXATION SYSTEM

Applicant: Integra Lifesciences Corp.
Product code: HRS
Advisory panel: Orthopedic
Date received: 2005-02-28
Decision date: 2005-03-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Planisboro, NJ, 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.