DeviceClearance

K193105

Substantially Equivalent

iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System, iTotal CR Knee Replacement System, iTotal PS Knee Replacement System

Applicant
Conformis, Inc.
Product code
JWH
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Billerica, MA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code JWH

product code JWH
Death
26
Injury
51,564
Malfunction
9,725
Other
9
Total
61,324

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.