DeviceClearance

K180612

Substantially Equivalent

Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts

Applicant
Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics
Product code
HSX
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 HSX

product code HSX
Injury
1,003
Other
1
Total
1,004

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.