FDA.reportPublic FDA data

SpinePlex

Primary DI
57613327141776
Brand
SpinePlex
Company
STRYKER CORPORATION
Model
0406222000
Catalog number
0406222000
Device description
Half Dose
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
NDNCEMENT, BONE, VERTEBROPLASTY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDNCement, Bone, VertebroplastyOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
37613327141772PackageGS12In Commercial Distribution
57613327141776PackageGS110In Commercial Distribution
07613327141771PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3761332714177237613327141772
5761332714177657613327141776
07613327141771076133271417717613327141771

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic cement, non-medicatedA substance designed to be used in arthroplastic and/or osteosynthetic procedures for the fixation of polymer or metallic implants to the living bone. It may also be intended for use as a filler in the case of bone pathologies (e.g., to stabilize and reinforce vertebral body structures in vertebroplasty and kyphoplasty). It is typically made from methylmethacrylate, polymethylmethacrylate (PMMA), esters of methacrylic acid or copolymers containing polymethylmethacrylate and polystyrene. This device does not contain an antimicrobial agent. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

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
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
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
08058964727817Winch Kyphoplasty Bilateral Kit 20 mmG21 SRLNDN2025-02-26
07613327545258AutoPlex VertaPlexSTRYKER CORPORATIONNDN2024-11-21
07613327638226OmnicurveSTRYKER CORPORATIONNDN2024-09-03
07613327638233OmnicurveSTRYKER CORPORATIONNDN2024-09-03
07613327638240OmnicurveSTRYKER CORPORATIONNDN2024-09-03