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
07613252450337ICONIX3910-500-5123910-500-5122015-08-26
07613252450344ICONIX3910-500-5223910-500-5222015-08-26
07613252450351ICONIX3910-500-5253910-500-5252015-08-26
07613252450368ICONIX3910-500-5323910-500-5322015-08-26
07613327176926ICONIX39105003123910-500-3122015-09-14
07613327176933ICONIX39105003223910-500-3222015-09-14
07613327283440ICONIX39105002123910-500-2122016-09-22
07613327298642Sonopet iQ55000083005500-008-3002019-05-03
07613327056952SERFAS Energy0279351100279-351-1002016-09-23
07613327056976SERFAS Energy0279351103279-351-1032016-09-23
07613327057027SERFAS Energy0279401100279-401-1002016-09-23
07613327057034SERFAS Energy02794012000279-401-2002016-09-23
07613327057041SERFAS Energy02793514000279-351-4002016-09-23
07613327058048CrossFlow045000000004500000002016-09-23
07613327294606NanoTackCAT02969CAT029692016-07-20
07613327643800NA79000620007900-062-0002025-12-19
07613327643824NA79001260007900-126-0002025-12-19
07613327643848NA79001250007900-125-0002025-12-19
00897146002025Adherus NUS-109NUS-1092016-12-19
00897146002018Adherus NUS-106NUS-1062015-04-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
07613327554724OmnicurveSTRYKER CORPORATIONNDN2023-11-07
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07640172551981VADER Pedicle System, Deburring toolicotec AGPML2023-01-13
07640172551998VADER Pedicle System, Trial rod, flexible, Ø 5.5 mm; L = 300 mmicotec AGPML2023-01-13
07640172552001VADER Pedicle System, Template for HT S-rodsicotec AGPML2023-01-13
07640172552018VADER Pedicle System, Template for TL S-rodsicotec AGPML2023-01-13
07640172552025VADER Pedicle System, Template for L S-rodsicotec AGPML2023-01-13
07640172552056VADER Pedicle System, Template for R120 & R450 curved rodsicotec AGPML2023-01-13
07640172552063VADER Pedicle System, Hexagon screw drivericotec AGPML2023-01-13
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
07640172552070VADER Pedicle System, Rod inserter, for cut rodsicotec AGPML2023-01-13
07640172551974VADER Pedicle System, Fixation deviceicotec AGPML2023-01-13
07640172552087VADER Pedicle System, K-wire, Ø 1.1 × 472 mmicotec AGPML2023-01-13
07640172551936VADER Pedicle System, VADER Pedicle System Rod-2-size, Container Baseicotec AGPML2023-01-13
07640172551943VADER Pedicle System, VADER Pedicle System Rod-2-size, Container Lidicotec 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