FDA.reportPublic FDA data

VertaPlex HV

Primary DI
07613327170559
Brand
VertaPlex HV
Company
STRYKER CORPORATION
Model
0406622015
Catalog number
0406-622-015
Device description
20 Gram Twin Pack (1/2 dose)
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LONSYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
MNIOrthosis, spinal pedicle fixation
NDNCEMENT, BONE, VERTEBROPLASTY
NKBThoracolumbosacral pedicle screw system
PMLbone cement, posterior screw augmentation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LONSystem, Test, Automated, Antimicrobial Susceptibility, Short IncubationMicrobiology2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2
NDNCement, Bone, VertebroplastyOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2
PMLBone Cement, Posterior Screw AugmentationOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
57613327170554PackageGS122In Commercial Distribution
07613327170559PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
5761332717055457613327170554
07613327170559076133271705597613327170559

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
+0018002533210INST.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
07613327652703N/A72000152707200-015-2702026-04-15
07613327652710PROstep72000150437200-015-0432026-04-13
07613327652727N/A72010157107201-015-7102026-04-13
07613327652734N/A72000153707200-015-3702026-04-13
07613154599127NA59200002045920-000-2042018-09-24
07613327413281Connected OR Hub02402001000240-200-1002023-07-26
07613327051674AIM SafeLight02330503000233-050-3002016-09-23
07613327056167SDC3024006010102400601012016-09-23
07613327056174SDC3024006010202400601022016-09-23
07613327382389168816880201221688-020-1222019-01-17
07613327405910Precision IE 4K0502-444-0700502-444-0702019-01-21
07613327405927Precision IE 4K0502-445-0300502-445-0302019-01-21
07613327405934Precision IE 4K0502-444-0100502-444-0102019-01-21
07613327405941Precision IE 4K0502-445-0700502-445-0702019-01-21
07613327405958Precision IE 4K0502-444-0300502-444-0302019-01-21
07613327405965Precision IE 4K0502-445-0100502-445-0102019-01-21
07613327405972Precision IE 4K0502-444-0450502-444-0452019-01-21
07613327405989Precision IE 4K0502-444-1300502-444-1302019-01-21
07613327416299Precision IE 4K0502-194-0100502-194-0102019-01-21
07613327416305Precision IE 4K0502-194-0300502-194-0302019-01-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840493423166RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423173RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423180RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423197RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423203RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423210RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423227RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423234RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423241RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423258RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423265RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423272RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423289RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423296RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423302RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423319RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423326RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423333RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423340RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423357RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423364RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423371RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423388RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423395RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423401RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423418RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423425RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423432RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423449RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423456RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08