AVAMAX VERTEBRAL BALLOON SYSTEM, 8G, AVAMAX VERTEBRAL BALLOON SYSTEM, 10G, AVAMAX VERTEBRAL BALLOON SYSTEM, 11G— 510(k) K131820

Substantially Equivalent

Care Fusion

FDA 510(k) clearance K131820 for AVAMAX VERTEBRAL BALLOON SYSTEM, 8G, AVAMAX VERTEBRAL BALLOON SYSTEM, 10G, AVAMAX VERTEBRAL BALLOON SYSTEM, 11G, Substantially Equivalent on 2013-10-04. Applicant: Care Fusion.

Clearance details

Applicant: Care Fusion
Product code: Code HRX
Advisory panel: Orthopedic
Date received: 2013-06-20
Decision date: 2013-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vernon Hills, IL, US

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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.