BALEX Bone Expander System TYP 0520

GUDID 08809281659325

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.

Taeyeon Medical co.,Ltd.

Kyphoplasty balloon catheter

• Primary Device ID: 08809281659325
• NIH Device Record Key: 94475e3a-f642-4518-88e5-e065f74bcb21
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BALEX Bone Expander System
• Version Model Number: BALEX TYP 0520
• Catalog Number: TYP 0520
• Company DUNS: 687607387
• Company Name: Taeyeon Medical co.,Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809281659325 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202027

FDA Product Code

• HXG: Tamp

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-01
• Device Publish Date: 2025-08-22

On-Brand Devices [BALEX Bone Expander System]

• 08809281659370: BALEX Bone Expander Systems are the device intended to insert the bone cement into the cavity ma
• 08809281659325: Kyphoplasty balloon catheter Definition: A sterile, flexible tube designed to be used for the cr
• 08809281659301: Kyphoplasty balloon catheter Definition: A sterile, flexible tube designed to be used for the cr