FDA.reportPublic FDA data

VertaPlex

Primary DI
07613327170566
Brand
VertaPlex
Company
STRYKER CORPORATION
Model
0406402015
Catalog number
0406-402-015
Device description
Radiopaque Bone Cement
Published
2016-09-23
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
LONSYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
NDNCEMENT, BONE, VERTEBROPLASTY
PMLbone cement, posterior screw augmentation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LONSystem, Test, Automated, Antimicrobial Susceptibility, Short IncubationMicrobiology2
NDNCement, Bone, VertebroplastyOrthopedic2
PMLBone Cement, Posterior Screw AugmentationOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
57613327170561PackageGS122In Commercial Distribution
07613327170566PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
5761332717056157613327170561
07613327170566076133271705667613327170566

GMDN Terms#

Term, Definition table
TermDefinition
Vertebral bone filler, non-bioabsorbableA sterile substance intended to be used to replace cortical/cancellous bone in a vertebral body to stabilize vertebral compression fractures (VCFs) caused by cancer, osteoporosis, or trauma. The device may be a sterile powder of a synthetic polymer [e.g., polymethylmethacrylate (PMMA)] that is mixed with its sterile diluent, or a non-PMMA-containing elastomer formed by mixing two precursors, prior to implantation typically during a balloon kyphoplasty or vertebroplasty procedure. This device does not contain an antibiotic agent. After application, this device cannot be reused.

Contacts#

Phone, Email table
PhoneEmail
+1(800)253-3210Inst.Stryker.cs@Stryker.com

Regulatory Flags#

DUNS number
196548481
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327524475Optablate97000151009700-015-1002022-09-23
07613327638233Omnicurve10320150001032-015-0002024-09-03
00857037006075LATERALATSYS24LATSYS242020-01-14
00857037006037LATERALATSYS20LATSYS202020-01-08
07613327060058Precision Ideal Eyes05028190100502-819-0102016-09-23
07613327006223ARIA48755700487557002019-11-20
07613327006919ES2 SPINAL SYSTEM48280082482800822019-11-20
07613327006926ES2 SPINAL SYSTEM48280083482800832019-11-20
07613327006940ES2 SPINAL SYSTEM48280086482800862019-11-20
07613327006957ES2 SPINAL SYSTEM48280087482800872019-11-20
07613327007114ES2 SPINAL SYSTEM48280311482803112019-11-25
07613327007558XIA 348237078482370782019-11-25
07613327007565XIA 348237079482370792019-11-25
07613327067088ACCULIF8003578003572016-09-24
07613327067095ACCULIF8003478003472016-09-24
07613327114799XIA 4.5 EVOLUTION48138140481381402019-11-21
07613327114812XIA 4.5 EVOLUTION48138011R48138011R2019-11-20
07613327114843XIA 4.5 EVOLUTION48138011L48138011L2019-11-20
07613327114850XIA 4.5 EVOLUTION48138101481381012019-11-21
07613327114874ES2 SPINAL SYSTEM48280178482801782019-11-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290117353738CarboClear Hybrid Pedicle Screw SystemCARBOFIX ORTHOPEDICS LTDPML2026-07-27
08809695579813Trocar Needle (Working Channel)GS Medical Co., Ltd.NDN2026-07-27
08809695579820Bevel Needle (Working Channel)GS Medical Co., Ltd.NDN2026-07-27
15099590799243MicroScanBeckman Coulter, Inc.LON2025-12-08
15099590799250MicroScanBeckman Coulter, Inc.LON2025-12-08
15099590807146MicroScanBeckman Coulter, Inc.LON2025-12-08
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 CORPORATIONNDN2024-09-03
07290117352113CarboClear Hybrid Pedicle Screw SystemCARBOFIX ORTHOPEDICS LTDPML2024-07-15
07613327554724OmnicurveSTRYKER CORPORATIONNDN2023-11-07
07613327554649OmnicurveSTRYKER CORPORATIONNDN2023-11-02
07640172551592VADER Pedicle System, Cannulated Tap, Ø 4.5 mmicotec AGPML2023-01-13
07640172551608VADER Pedicle System, Cannulated Tap MIS, Ø 4.5 mmicotec AGPML2023-01-13
07640172551530VADER Pedicle System ,Screw, Carbon/PEEK, Polyax., Fen., Ø 4.5 × 25 mmicotec AGPML2023-01-12
07640172551547VADER Pedicle System ,Screw, Carbon/PEEK, Polyax., Fen., Ø 4.5 × 30 mmicotec AGPML2023-01-12
07640172551554VADER Pedicle System ,Screw, Carbon/PEEK, Polyax., Fen., Ø 4.5 × 35 mmicotec AGPML2023-01-12
07640172551561VADER Pedicle System ,Screw, Carbon/PEEK, Polyax., Fen., Ø 4.5 × 40 mmicotec AGPML2023-01-12
07640172551578VADER Pedicle System ,Screw, Carbon/PEEK, Polyax., Fen., Ø 4.5 × 45 mmicotec AGPML2023-01-12
07640172551585VADER Pedicle System ,Screw, Carbon/PEEK, Polyax., Fen., Ø 4.5 × 50 mmicotec AGPML2023-01-12
07640172551615VADER Pedicle System, Rod, Carbon/PEEK, Straight, Ø 6.0 r000 x 040 mmicotec AGPML2023-01-12
07640172551622VADER Pedicle System, Rod, Carbon/PEEK, Straight, Ø 6.0 r000 x 050 mmicotec AGPML2023-01-12
07640172551639VADER Pedicle System, Rod, Carbon/PEEK, Straight, Ø 6.0 r000 x 060 mmicotec AGPML2023-01-12
07640172551646VADER Pedicle System, Rod, Carbon/PEEK, Straight, Ø 6.0 r000 x 070 mmicotec AGPML2023-01-12
07640172551653VADER Pedicle System, Rod, Carbon/PEEK, Straight, Ø 6.0 r000 x 080 mmicotec AGPML2023-01-12
07640172551660VADER Pedicle System, Rod, Carbon/PEEK, Straight, Ø 6.0 r000 x 090 mmicotec AGPML2023-01-12