DeviceClearance

K083009

Substantially Equivalent

ORTHO-MAP-ONCOLOGY NAVIGATION SOFTWARE, MODELS 6005-650-000, 6005-651-000

Applicant
Stryker Leibinger GmbH & Co KG
Product code
OLO
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Freiburg Baden-Wurttemberg, DE
Download summary PDF View on FDA.gov ↗

Adverse events under product code OLO

product code OLO
Death
11
Injury
2,799
Malfunction
11,105
Other
1
Total
13,916

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.