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: 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. FDA UDI
Model / Reference: BALEX TYP 0515 FDA UDI
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. FDA UDI

Identifiers

Catalog Number: TYP 0515 FDA UDI
Primary DI / UDI-DI: 08809281659370 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

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

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

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Cleared under the same submission

K202027 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Taeyeon Medical Co., Ltd.

Sources (1)

FDA UDI f09a1ed1-a445-4784-ac21-ba26825328b5 35 fields · synced Jun 8, 2026