AVAMAX VERTEBRAL BALLOON— 510(k) K103064

Substantially Equivalent

Care Fusion

FDA 510(k) clearance K103064 for AVAMAX VERTEBRAL BALLOON, Substantially Equivalent on 2011-01-10. Applicant: Care Fusion.

Clearance details

Applicant: Care Fusion
Product code: Code NDN
Advisory panel: Orthopedic
Date received: 2010-10-18
Decision date: 2011-01-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waukegan, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code NDN

product code NDN

Death: 24
Injury: 407
Malfunction: 1,975
Total: 2,406

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.