DeviceClearance

K161280

Substantially Equivalent

Cervical Stand Alone System

Applicant
Orthofix, Inc.
Product code
OVE
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Lewisville, TX, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code OVE

product code OVE
Injury
293
Malfunction
710
Total
1,003

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.