FDA.reportPublic FDA data

V-STRUT Vertebral Implant

Primary DI
03770007907752
Brand
V-STRUT Vertebral Implant
Company
Hyprevention Inc.
Model
34525
Catalog number
34525
Device description
V-STRUT© Vertebral Implant 4.5-L25
Published
2024-02-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03770007907752PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03770007907752037700079077523770007907752

GMDN Terms#

Term, Definition table
TermDefinition
Vertebral body prosthesisAn implantable device designed to replace one or more vertebral body(s) that has collapsed or been surgically removed due to trauma, tumour or degenerative disease. Also known as a corpectomy or vertebrectomy spacer, it is in the form of a one-piece or modular hollow cylinder made of inorganic materials (e.g., metal, polymer). It is typically used with supplemental spinal fixation and/or bone graft, and some types are adjustable for in situ adjustment of prosthesis height to allow intraoperative distraction of adjacent vertebrae.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length25Millimeter
Outer Diameter4.5Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
119225096
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03770007907424V-STRUT Guide Wire32300323002025-06-26
03770007907431V-STRUT Drill 4.5mm34500345002025-06-26
03770007907448V-STRUT Drill 5.5mm35500355002025-06-26
03770007907455V-STRUT Drill 6.5mm36500365002025-06-26
03770007907462V-STRUT Tube32010320102025-06-26
03770007907479V-STRUT Dilator32020320202025-06-26
03770007907486V-STRUT Gripper32050320502025-06-26
03770007907493V-STRUT Positioner32060320602025-06-26
03770007907509V-STRUT Container32400324002025-06-26
03770007907516V-STRUT Instrumentation set32500325002025-06-26
03770007907769V-STRUT Vertebral Implant34530345302024-02-27
03770007907776V-STRUT Vertebral Implant34535345352024-02-27
03770007907783V-STRUT Vertebral Implant34540345402024-02-27
03770007907790V-STRUT Vertebral Implant34560345602024-02-27
03770007907806V-STRUT Vertebral Implant34545345452024-02-27
03770007907813V-STRUT Vertebral Implant34550345502024-02-27
03770007907820V-STRUT Vertebral Implant34555345552024-02-27
03770007907523V-STRUT Vertebral Implant35540355402021-03-05
03770007907530V-STRUT Vertebral Implant35545355452021-03-05
03770007907547V-STRUT Vertebral Implant35550355502021-03-05

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 GmbHNDN2025-09-26
04260102139411OSTEOPAL®Heraeus Medical GmbHLOD2025-09-26
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 CORPORATIONNDN2024-11-21
07613327545258AutoPlex VertaPlexSTRYKER CORPORATIONLOD2024-11-21
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