FDA.reportPublic FDA data

SpinePlex

Primary DI
07613327141788
Brand
SpinePlex
Company
STRYKER CORPORATION
Model
0406202010
Catalog number
0406-202-010
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
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LONSYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
NDNCEMENT, BONE, VERTEBROPLASTY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LONSystem, Test, Automated, Antimicrobial Susceptibility, Short IncubationMicrobiology2
NDNCement, Bone, VertebroplastyOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327141788PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327141788076133271417887613327141788

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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
08800038029323SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08800038029330SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08800038029347SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08800038029354SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08800038029361SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08800038029378SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08800038029415SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08800038029422SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08800038039407SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08800038039414SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08800038039421SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08800038039438SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08800038039445SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08800038039452SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08800038039469SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08800038039476SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08058964726452Winch Kyphoplasty Kit 15 mmG21 SRLNDN2025-02-26
08058964726469Winch Kyphoplasty Kit 20 mmG21 SRLNDN2025-02-26
08058964726735Winch Kyphoplasty Bilateral Kit 15 mmG21 SRLNDN2025-02-26
08058964727589EasyWinch 15 mmG21 SRLNDN2025-02-26
08058964727596EasyWinch 20 mmG21 SRLNDN2025-02-26
08058964727763Winch Kyphoplasty Kit 8G 15 mmG21 SRLNDN2025-02-26
08058964727770Winch Kyphoplasty Bilateral Kit 8G 15 mmG21 SRLNDN2025-02-26
08058964727787Winch Kyphoplasty Kit 8G 20 mmG21 SRLNDN2025-02-26
08058964727794Winch Kyphoplasty Bilateral Kit 8G 20 mmG21 SRLNDN2025-02-26