DeviceClearance

AVAflex Vertebral Balloon System— 510(k) K151125

Substantially Equivalent

Care Fusion

FDA 510(k) clearance K151125 for AVAflex Vertebral Balloon System, Substantially Equivalent on 2015-11-24. Applicant: Care Fusion.

Clearance details

Applicant
Care Fusion
Product code
Code HRX
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Vernon Hills, IL, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code HRX

product code HRX
Injury
623
Malfunction
11,257
Total
11,880

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.