AVAFLEX VERTEBRAL BALLOON SYSTEM— 510(k) K131824

Substantially Equivalent

Care Fusion

FDA 510(k) clearance K131824 for AVAFLEX VERTEBRAL BALLOON SYSTEM, Substantially Equivalent on 2013-10-03. Applicant: Care Fusion.

Clearance details

Applicant: Care Fusion
Product code: Code HRX
Advisory panel: Orthopedic
Date received: 2013-06-20
Decision date: 2013-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vernon Hills, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HRX

product code HRX

Injury: 623
Malfunction: 11,257
Total: 11,880

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.