DeviceClearance

K090705

Substantially Equivalent

BALANCED KNEE SYSTEM ULTRACONGRUENT TIBIAL INSERT

Applicant
Ortho Development Corp.
Product code
JWH
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Draper, UT, 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.