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BALEX Bone Expander System

Taeyeon Medical co.,Ltd. · Model BALEX TYP 0515 · UDI-DI 08809281659370

HXG NDN HRX Prescription

510(k) clearances

160

Adverse events (7 deaths)

Recalls

234

Facilities

Description

BALEX Bone Expander Systems are the device intended to insert the bone cement into the cavity made by the balloon tip in the fractures of the spinal bone. The kit box includes 1 kit which contains the Balloon Expander and Catheter.

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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.