FDA.reportPublic FDA data

VertaPlex

Primary DI
07613327141764
Brand
VertaPlex
Company
STRYKER CORPORATION
Model
0406402002
Catalog number
0406-402-002
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
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
37613327141765PackageGS110In Commercial Distribution
57613327141769PackageGS12In Commercial Distribution
07613327141764PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3761332714176537613327141765
5761332714176957613327141769
07613327141764076133271417647613327141764

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
07613327651188VersiQuad0234112600234-112-6002026-07-22
07613252193791Neuroform3M003SNF325150M003SNF3251502015-05-29
07613252193845Neuroform3M003SNF335100M003SNF3351002015-05-29
07613252193913Neuroform3M003SNF345100M003SNF3451002015-05-29
07613154599127NA59200002045920-000-2042018-09-24
04546540434364SpinePlex04062020000406-202-0002016-06-30
07613154599097NA59200002015920-000-2012016-09-23
07613154599103NA59200002025920-000-2022018-09-24
07613154599110NA59200002035920-000-2032018-09-24
07613154599134NA59200002055920-000-2052018-09-24
07613154599141NA59200002065920-000-2062018-09-24
07613154599158NA59200002075920-000-2072018-09-24
07613154599165NA59200002085920-000-2082018-09-24
07613154599172NA59200002095920-000-2092018-09-24
07613154599189NA59200003015920-000-3012018-09-24
07613154599196NA59200003025920-000-3022018-09-24
07613154599202NA59200003035920-000-3032018-09-24
07613154599219NA59200003045920-000-3042018-09-24
07613154599226NA59200003055920-000-3052018-09-24
07613154599233NA59200003065920-000-3062018-09-24

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
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
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