FDA.reportPublic FDA data

KIT: VCF Treatment, RIGHT, FRACTURE

Primary DI
00815212024443
Brand
KIT: VCF Treatment, RIGHT, FRACTURE
Company
Izi Medical Products, LLC
Model
KIVA2100E
Published
2020-08-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LODBone Cement
NDNCement, Bone, Vertebroplasty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LODBone CementOrthopedic2
NDNCement, Bone, VertebroplastyOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141141000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141141000KIVA VCF TREATMENT SYSTEMBenvenue Medical, Inc.2014-08-14NDN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815212024443PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815212024443008152120244438152120244430815212024443

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic cement, non-antimicrobialA substance designed to be used in arthroplastic and/or osteosynthetic procedures for the fixation of polymer or metallic implants to the living bone. It may also be intended for use as a filler in the case of bone pathologies (e.g., to stabilize and reinforce vertebral body structures in vertebroplasty and kyphoplasty). It is typically made from methylmethacrylate, polymethylmethacrylate (PMMA), esters of methacrylic acid or copolymers containing polymethylmethacrylate and polystyrene; it does not contain an antimicrobial agent. Disposable devices dedicated to introduction, preparation or delivery may be packaged with the cement. After application, this device cannot be reused.

Regulatory Flags#

DUNS number
933506164
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
00815212026928KIT:BALLOON,FILLER,ACCESS,DRILLVBBF0022024-08-28
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
00815212024450KIT: VCF Treatment, LEFT, FRACTUREKIVA2200E2020-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450843215StabiliT®Merit Medical Systems, Inc.NDN2026-04-15
00884450843222StabiliT®Merit Medical Systems, Inc.NDN2026-03-31
03760177044326Signature -x CementTEKNIMEDLOD2026-01-23
03760177044333Signature -x CementTEKNIMEDLOD2026-01-23
03760177044340Signature -x CementTEKNIMEDLOD2026-01-23
04260102139411OSTEOPAL®Heraeus Medical GmbHLOD2025-09-26
04260102139411OSTEOPAL®Heraeus Medical GmbHNDN2025-09-26
03760177040090GENTAFIXTEKNIMEDLOD2025-09-02
03760177040137GENTAFIXTEKNIMEDLOD2025-09-02
03760177043176GENTAFIXTEKNIMEDLOD2025-09-02
07898315500901Bone Cement - Normal ViscosityBiomecânica Indústria e Comércio de Produtos Ortopédicos Ltda.LOD2025-04-23
00815212026966OS 11G BONE FILLER KIT-OSTEOFIXIzi Medical Products, LLCNDN2025-03-26
00889095358230CONCORDGLOBUS MEDICAL, INC.NDN2024-12-01
00889095358247CONCORDGLOBUS MEDICAL, INC.NDN2024-12-01
07613327545258AutoPlex VertaPlexSTRYKER CORPORATIONLOD2024-11-21
07613327545258AutoPlex VertaPlexSTRYKER CORPORATIONNDN2024-11-21
08058964729033Arthrex Bone Cement HVG21 SRLLOD2024-10-04
08058964729040Arthrex Bone Cement MVG21 SRLLOD2024-10-04
08058964728647Arthrex Bone Cement HVG21 SRLLOD2024-09-16
08058964728678BRAVO HVG21 SRLLOD2024-09-16
08058964728722Arthrex Bone Cement HV w/GG21 SRLLOD2024-09-16
08058964728739Arthrex Bone Cement MVG21 SRLLOD2024-09-16
08058964728746Arthrex Bone Cement MV w/GG21 SRLLOD2024-09-16
08058964729002BRAVO MVG21 SRLLOD2024-09-16
08058964729019BRAVO MV+GG21 SRLLOD2024-09-16
08058964729026BRAVO HV+GG21 SRLLOD2024-09-16
00815212026911KIT:BALLOON AND BONE FILLERIzi Medical Products, LLCNDN2024-08-28
00815212026928KIT:BALLOON,FILLER,ACCESS,DRILLIzi Medical Products, LLCNDN2024-08-28
04260056882579BonOs HVOSARTIS GmbHLOD2024-05-17
04260056882623BonOs HV GentaOSARTIS GmbHLOD2024-04-03