FDA.reportPublic FDA data

GUARDIAN Inflatable Bone Expander System

Primary DI
08809255542219
Brand
GUARDIAN Inflatable Bone Expander System
Company
BM KOREA CO., LTD
Model
BMK-CM
Device 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.
Published
2018-02-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HRXArthroscope
NDNCement, Bone, Vertebroplasty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRXArthroscopeOrthopedic2
NDNCement, Bone, VertebroplastyOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111593000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111593000GUARDIAN INFLATABLE BONE EXPANDER SYSTEMBm Korea Co., Ltd.2011-11-18NDN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809255544213PackageGS110In Commercial Distribution
08809255542219PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809255544213088092555442138809255544213
08809255542219088092555422198809255542219

GMDN Terms#

Term, Definition table
TermDefinition
Catheter/overtube balloon inflator, single-useA device designed to inflate and regulate the pressure of the balloon of a catheter, endoscopic overtube, or other invasive device (e.g., tamp, endomicroscopy probe), typically by injecting and aspirating fluid or air within the balloon, and to deflate the balloon during a medical procedure. It typically consists of a dedicated manual syringe/plunger or electronic mechanism for inflation/deflation, an analogue or digital gauge/screen for monitoring pressure, a locking mechanism, and a connecting tube. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length229.58Millimeter

Regulatory Flags#

DUNS number
557799209
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809255540024Galaxy Mis Screw SystemGXMS-55302017-07-11
08809255540031Galaxy Mis Screw SystemGXMS-55352017-07-14
08809255540048Galaxy Mis Screw SystemGXMS-55402017-07-14
08809255540055Galaxy Mis Screw SystemGXMS-55452017-07-14
08809255540062Galaxy Mis Screw SystemGXMS-55502017-07-14
08809255540079Galaxy Mis Screw SystemGXMS-55552017-07-14
08809255540086Galaxy Mis Screw SystemGXMS-55602017-07-14
08809255540093Galaxy Mis Screw SystemGXMS-65302017-07-14
08809255540109Galaxy Mis Screw SystemGXMS-65352017-07-14
08809255540116Galaxy Mis Screw SystemGXMS-65402017-07-14
08809255540123Galaxy Mis Screw SystemGXMS-65452017-07-14
08809255540130Galaxy Mis Screw SystemGXMS-65502017-07-14
08809255540147Galaxy Mis Screw SystemGXMS-65552017-07-14
08809255540154Galaxy Mis Screw SystemGXMS-65602017-07-14
08809255540161Galaxy Mis Screw SystemGXMS-75302017-07-14
08809255540178Galaxy Mis Screw SystemGXMS-75352017-07-14
08809255540185Galaxy Mis Screw SystemGXMS-75402017-07-14
08809255540192Galaxy Mis Screw SystemGXMS-75452017-07-14
08809255540208Galaxy Mis Screw SystemGXMS-75502017-07-14
08809255540215Galaxy Mis Screw SystemGB300-55352017-07-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00846338001209IEC BiPolar Cable, DisposableELLIQUENCE, LLCHRX2026-06-03
00846338001230Bipolar CableELLIQUENCE, LLCHRX2026-06-03
00846338001247Bipolar Cable - 2 Flat ProngsELLIQUENCE, LLCHRX2026-06-03
00846338001537Bipolar Cable - 2 Flat ProngsELLIQUENCE, LLCHRX2026-06-03
00846338001582IEC Power Cord 110vELLIQUENCE, LLCHRX2026-06-03
00846338001605IEC Power Cord 220v ANZ PlugELLIQUENCE, LLCHRX2026-06-03
00846338001612IEC Power Cord 220v EuropeELLIQUENCE, LLCHRX2026-06-03
00846338001629IEC Power Cord U.K. 220vELLIQUENCE, LLCHRX2026-06-03
00846338007140BiPolar Cable, DisposableELLIQUENCE, LLCHRX2026-06-02
00846338005146Neutral PlateELLIQUENCE, LLCHRX2026-06-01
00846338005320Needle PunchELLIQUENCE, LLCHRX2026-06-01
07613327601695Connected OR HubSTRYKER CORPORATIONHRX2025-06-04
07613327601701SDC4K Information Management SystemSTRYKER CORPORATIONHRX2025-06-04
08058964726452Winch Kyphoplasty Kit 15 mmG21 SRLNDN2025-02-26
08058964726469Winch Kyphoplasty Kit 20 mmG21 SRLNDN2025-02-26
08058964726735Winch Kyphoplasty Bilateral Kit 15 mmG21 SRLNDN2025-02-26
08058964727589EasyWinch 15 mmG21 SRLNDN2025-02-26
08058964727596EasyWinch 20 mmG21 SRLNDN2025-02-26
08058964727763Winch Kyphoplasty Kit 8G 15 mmG21 SRLNDN2025-02-26
08058964727770Winch Kyphoplasty Bilateral Kit 8G 15 mmG21 SRLNDN2025-02-26
08058964727787Winch Kyphoplasty Kit 8G 20 mmG21 SRLNDN2025-02-26
08058964727794Winch Kyphoplasty Bilateral Kit 8G 20 mmG21 SRLNDN2025-02-26
08058964727817Winch Kyphoplasty Bilateral Kit 20 mmG21 SRLNDN2025-02-26
07613327545258AutoPlex VertaPlexSTRYKER CORPORATIONNDN2024-11-21
07613327638226OmnicurveSTRYKER CORPORATIONNDN2024-09-03
07613327638233OmnicurveSTRYKER CORPORATIONNDN2024-09-03
07613327638240OmnicurveSTRYKER CORPORATIONNDN2024-09-03
07613327638257OmnicurveSTRYKER CORPORATIONNDN2024-09-03
07613327638431OmnicurveSTRYKER CORPORATIONNDN2024-09-03
07613327638448OmnicurveSTRYKER CORPORATIONHRX2024-09-03