DeviceClearance

K082022

Substantially Equivalent

OPTETRAK 9MM CRUCIATE RETAINING TIBIAL INSERT, SLOPE ++

Applicant
Exactech, Inc.
Product code
JWH
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Gainesville, FL, 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.