FDA.reportPublic FDA data

VertaPlex

Primary DI
07613154757091
Brand
VertaPlex
Company
STRYKER CORPORATION
Model
0406402000
Catalog number
0406-402-000
Device description
RadioPaque Bone Cement
Published
2016-06-30
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
LODBONE CEMENT
NDNCEMENT, BONE, VERTEBROPLASTY
PMLbone cement, posterior screw augmentation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LODBone CementOrthopedic2
NDNCement, Bone, VertebroplastyOrthopedic2
PMLBone Cement, Posterior Screw AugmentationOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
37613154757092PackageGS12In Commercial Distribution
07613154757091PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3761315475709237613154757092
07613154757091076131547570917613154757091

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
07613327635096InZone ISTIST345100960IST3451009602026-07-08
07613327638233Omnicurve10320150001032-015-0002024-09-03
07613327554724Omnicurve1033-130-0001033-130-0002023-11-07
07613327554687Omnicurve1033-115-0001033-115-0002022-04-12
07613327554700Omnicurve1033-120-0001033-120-0002022-04-12
07613327638226Omnicurve10330150001033-015-0002024-09-03
07613327638240Omnicurve10320200001032-020-0002024-09-03
07613327638257Omnicurve10330300001033-030-0002024-09-03
07613327638431Omnicurve10330200001033-020-0002024-09-03
07613327638448Omnicurve10320300001032-030-0002024-09-03
07613327554649Omnicurve1032-130-0001032-130-0002023-11-02
07613327413281Connected OR Hub02402001000240-200-1002023-07-26
07613327554663Omnicurve1032-120-0001032-120-0002022-04-12
07613327051674AIM SafeLight02330503000233-050-3002016-09-23
07613327056167SDC3024006010102400601012016-09-23
04546540722768WingspanM003WS0250090M003WS02500902015-05-29
04546540722775WingspanM003WS0250150M003WS02501502015-05-29
04546540722782WingspanM003WS0250200M003WS02502002015-05-29
04546540722799WingspanM003WS0300090M003WS03000902015-05-29
04546540722805WingspanM003WS0300150M003WS03001502015-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327545258AutoPlex VertaPlexSTRYKER CORPORATIONNDN2024-11-21
07613327545258AutoPlex VertaPlexSTRYKER CORPORATIONLOD2024-11-21
07613327638226OmnicurveSTRYKER CORPORATIONNDN2024-09-03
07613327638233OmnicurveSTRYKER CORPORATIONNDN2024-09-03
07613327638240OmnicurveSTRYKER CORPORATIONNDN2024-09-03
07613327638257OmnicurveSTRYKER CORPORATIONNDN2024-09-03
07613327638431OmnicurveSTRYKER CORPORATIONNDN2024-09-03
07613327638448OmnicurveSTRYKER CORPORATIONNDN2024-09-03
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
07640172551677VADER Pedicle System, Rod, Carbon/PEEK, Straight, Ø 6.0 r000 x 100 mmicotec AGPML2023-01-12
07640172551684VADER Pedicle System, Rod, Carbon/PEEK, Straight, Ø 6.0 r000 x 120 mmicotec AGPML2023-01-12
07640172551691VADER Pedicle System, Rod, Carbon/PEEK, Straight, Ø 6.0 r000 x 140 mmicotec AGPML2023-01-12
07640172551707VADER Pedicle System, Rod, Carbon/PEEK, Straight, Ø 6.0 r000 x 160 mmicotec AGPML2023-01-12
07640172551714VADER Pedicle System, S-Rod, Carbon/PEEK, multi-curved, HT1, Ø 6.0 x 300 mmicotec AGPML2023-01-12
07640172551721VADER Pedicle System, S-Rod, Carbon/PEEK, multi-curved, HT2, Ø 6.0 x 300 mmicotec AGPML2023-01-12