DeviceClearance

K251315

Substantially Equivalent

Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II

Applicant
Remex Medical Corp.
Product code
OLO
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Taichung, TW
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.