BALEX Bone Expander System TYP 0515

GUDID 08809281659370

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.

Taeyeon Medical co.,Ltd.

Kyphoplasty balloon catheter

• Primary Device ID: 08809281659370
• NIH Device Record Key: f09a1ed1-a445-4784-ac21-ba26825328b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BALEX Bone Expander System
• Version Model Number: BALEX TYP 0515
• Catalog Number: TYP 0515
• 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	08809281659370 [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