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BALEX Bone Expander System

FDA UDI

Class I (US FDA UDI)

by Taeyeon Medical Co., Ltd.

Identity

Trade Name
BALEX Bone Expander System FDA UDI
Generic Name
Kyphoplasty balloon catheter FDA UDI
Device Name
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. FDA UDI
Model / Reference
BALEX TYP 0520 FDA UDI
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. FDA UDI

Identifiers

Catalog Number
TYP 0520 FDA UDI
Primary DI / UDI-DI
08809281659325 FDA UDI
510(k) Number
K202027 FDA UDI
FDA Product Code
HXG FDA UDI
NDN FDA UDI
HRX FDA UDI
GMDN Term
Kyphoplasty balloon catheter FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 FDA UDI
888.3027 FDA UDI
888.1100 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Kyphoplasty balloon catheter

BALEX Bone Expander System by Taeyeon Medical Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Kyphoplasty balloon catheter.

Cleared under the same submission

K202027 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Taeyeon Medical Co., Ltd.

Sources (1)

  • FDA UDI 94475e3a-f642-4518-88e5-e065f74bcb21 35 fields · synced May 30, 2026