GUARDIAN Inflatable Bone Expander System

FDA UDI

Class II (US FDA UDI)

by Bm Korea Co., Ltd

Identity

Trade Name: GUARDIAN Inflatable Bone Expander System FDA UDI
Generic Name: Catheter/overtube balloon inflator, single-use FDA UDI
Device Name: The GUARDIAN Inflatable Bone Expander System is designed to reduce spinal compression fracture and restore sagittal alignment. By creating a space in the vertebral body to facilitate the insertion of bone cement and using cement dispensing plunger, the major benefits of GUARDIAN Inflatable Bone Expander System are the significant reduction in back pain and increase patient’s functional abilities, allow a return it the previous level of activity. FDA UDI
Model / Reference: BMK15BC FDA UDI
Description: The GUARDIAN Inflatable Bone Expander System is designed to reduce spinal compression fracture and restore sagittal alignment. By creating a space in the vertebral body to facilitate the insertion of bone cement and using cement dispensing plunger, the major benefits of GUARDIAN Inflatable Bone Expander System are the significant reduction in back pain and increase patient’s functional abilities, allow a return it the previous level of activity. FDA UDI

Identifiers

Primary DI / UDI-DI: 08809255542165 FDA UDI
510(k) Number: K111593 FDA UDI
FDA Product Code: HRX FDA UDI
NDN FDA UDI
GMDN Term: Catheter/overtube balloon inflator, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.1100 FDA UDI
888.3027 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

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

Dimensions & Sizes

Size: Length — 303 Millimeter FDA UDI

Category: Catheter/overtube balloon inflator, single-use

GUARDIAN 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

K111593 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 II	Pending data

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Manufacturer

Manufacturer: Bm Korea Co., Ltd

Sources (1)

FDA UDI 5d905f34-f42b-4592-9eaf-6e161dc77cf0 35 fields · synced May 30, 2026