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BALEX Bone Expander System

Taeyeon Medical co.,Ltd. · Model BALEX TYP 0510 · UDI-DI 08809281659301

HXG NDN HRX Prescription

510(k) clearances

160

Adverse events (7 deaths)

Recalls

234

Facilities

Description

Kyphoplasty balloon catheter Definition: A sterile, flexible tube designed to be used for the creation of a void within a vertebral body during a minimally invasive procedure commonly known as balloon kyphoplasty. It is manually inserted percutaneously through an access channel under fluoroscopic guidance to a vertebral compression fracture (VCF) site (e.g., in the lumbar or thoracic region of the spine) where its balloon is inflated with a medium (e.g., a liquid contrast medium) to force the vertebrae apart for insertion of bone cement; thereafter it is deflated and removed via the access channel. This is a single-use device.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.