DeviceClearance

K241644

Substantially Equivalent

SPINEART Navigation Instrument System

Applicant
Spineart SA
Product code
OLO
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Plan-Les-Ouates, CH
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.