DeviceClearance

K161060

Substantially Equivalent

Arthrex iBalance UKA System Vitamin E Tibial Bearing

Applicant
Arthrex, Inc.
Product code
HSX
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Naples, FL, 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.