GUARDIAN-SG Inflatable Bone Expander System

FDA UDI

Class II (US FDA UDI)

by Bm Korea Co., Ltd

Identity

Trade Name: GUARDIAN-SG Inflatable Bone Expander System FDA UDI
Generic Name: Catheter/overtube balloon inflator, single-use FDA UDI
Device Name: The GUARDIAN-SG Inflatable Bone Expander System is intended to be used for the reduction of fracture and/or creation of a void in cancellous bone in the spine. FDA UDI
Model / Reference: BMK(T)15αS FDA UDI
Description: The GUARDIAN-SG Inflatable Bone Expander System is intended to be used for the reduction of fracture and/or creation of a void in cancellous bone in the spine. FDA UDI

Identifiers

Primary DI / UDI-DI: 08809255542639 FDA UDI
510(k) Number: K143006 FDA UDI
FDA Product Code: NDN FDA UDI
HRX FDA UDI
GMDN Term: Catheter/overtube balloon inflator, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Catheter/overtube balloon inflator, single-use

GUARDIAN-SG Inflatable Bone Expander System by Bm Korea Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K143006 also covers:

GUARDIAN-SG Inflatable Bone Expander System — BM KOREA CO., LTD

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 II	Pending data

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Manufacturer

Manufacturer: Bm Korea Co., Ltd

Sources (1)

FDA UDI 91e119ef-2f23-4c20-b3d4-7f7af07a8d6f 35 fields · synced May 30, 2026