FDA.reportPublic FDA data

KIT:BALLOON,FILLER,ACCESS,DRILL

Primary DI
00815212026928
Brand
KIT:BALLOON,FILLER,ACCESS,DRILL
Company
Izi Medical Products, LLC
Model
VBBF002
Published
2024-08-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HRXArthroscope
KNWInstrument, Biopsy
NDNCement, Bone, Vertebroplasty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRXArthroscopeOrthopedic2
KNWInstrument, BiopsyGastroenterology, Urology2
NDNCement, Bone, VertebroplastyOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815212026928PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815212026928008152120269288152120269280815212026928

GMDN Terms#

Term, Definition table
TermDefinition
Balloon kyphoplasty kitA collection of sterile surgical instruments and devices used for the reduction of a vertebral compression fractures (VCFs) caused by trauma, cancer, or osteoporosis during a minimally invasive procedure commonly known as balloon kyphoplasty. It typically consists of a bone access needle, an osteo introducer, an inflation syringe, and the inflatable bone tamp. This procedure involves the insertion of the balloon tamp into a patient's back to reduce a vertebral body fracture by compression of cancellous bone and/or movement of the endplates as the balloon is inflated, and filling the void created with orthopaedic cement/filler to stabilize the vertebra. This is a single-use device.

Regulatory Flags#

DUNS number
933506164
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815212026966OS 11G BONE FILLER KIT-OSTEOFIXG800122025-03-26
00815212026935Duro-Ject Bone Cement Injection TubeG135502024-10-14
00815212026911KIT:BALLOON AND BONE FILLERVBBF0012024-08-28
00815212026775Vertefix MVG900062024-02-16
00815212026782Osteo-site VCF Kit, Vertefix MV CementG800092024-02-16
00815212026799Osteo-site Bone Filler Kit-MVG800102024-02-16
00815212026805Osteo-site Bone Filler Kit-MVG800112024-02-16
00815212026362Bone Filler Kit-HV EUG80007E2022-05-04
00815212026393Pair Rotating Luer Lock ConnectorsASC00102022-03-22
00815212023019CMM4G373742021-10-15
00815212023446CMM1G900042021-10-15
00815212024429VCF-400G800042021-05-26
00815212024627Cement: Vertefix HVG900052021-05-26
00815212025570OS Bone Filler Kit-HVG800072021-05-26
00815212024351VCF-300G800022021-05-18
00815212024368VCF-100-PLG800032021-05-18
00815212024337VCF-000G800002021-05-14
00815212024344VCF-200G800012021-05-14
00815212024443KIT: VCF Treatment, RIGHT, FRACTUREKIVA2100E2020-08-27
00815212024450KIT: VCF Treatment, LEFT, FRACTUREKIVA2200E2020-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000749903CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NDN2026-10-23
00763000750510CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NDN2026-10-23
04250337121015Combo Optic AdapterJoimax GmbHHRX2026-10-19
08058964729767Easy Winch 13 G, 15 mmG21 SRLHRX2026-10-19
08058964729767Easy Winch 13 G, 15 mmG21 SRLNDN2026-10-19
08058964729774Easy Winch 13 G, 10 mmG21 SRLNDN2026-10-19
08058964729774Easy Winch 13 G, 10 mmG21 SRLHRX2026-10-19
00763000750053CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NDN2026-10-16
00763000750251CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NDN2026-10-16
00763000750268CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NDN2026-10-16
00763000750275CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NDN2026-10-16
00763000750374CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NDN2026-10-16
00763000750404CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NDN2026-10-16
00817295020589InradInradKNW2026-10-09
00817295021081InradInradKNW2026-10-08
00817295021098InradInradKNW2026-10-08
00817295021104InradInradKNW2026-10-08
00817295021111InradInradKNW2026-10-08
00817295021128InradInradKNW2026-10-08
00817295021135InradInradKNW2026-10-08
00817295021142InradInradKNW2026-10-08
00817295021159InradInradKNW2026-10-08
00817295021357InradInradKNW2026-10-08
00817295021364InradInradKNW2026-10-08
00817295021371InradInradKNW2026-10-08
06937278634245CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06937278644121CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-06-30
00884450843215StabiliT®Merit Medical Systems, Inc.NDN2026-04-15
00884450843222StabiliT®Merit Medical Systems, Inc.NDN2026-03-31
04260102139411OSTEOPAL®Heraeus Medical GmbHNDN2025-09-26