DeviceClearance

K253637

Substantially Equivalent

Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert

Applicant
Howmedica Osteonics Corp., Dba Stryker Orthopaedics
Product code
MBH
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mahwah, NJ, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code MBH

product code MBH
Injury
6,545
Malfunction
2,023
Total
8,568

Source: openFDA MAUDE database, through . 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.