FDA.reportPublic FDA data

SpinePlex

Primary DI
34546540434365
Brand
SpinePlex
Company
STRYKER CORPORATION
Model
0406202000
Catalog number
0406-202-000
Device description
Radiopaque Bone Cement
Published
2016-06-30
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
34546540434365PackageGS12In Commercial Distribution
54546540434369PackageGS110In Commercial Distribution
04546540434364PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3454654043436534546540434365
5454654043436954546540434369
04546540434364045465404343644546540434364

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
07613327687637N/A65170400166517-040-0162026-03-19
07613327687644N/A65170400106517-040-0102026-03-19
07613327687651N/A65170700216517-070-0212026-03-19
07613327687668N/A65170480216517-048-0212026-03-19
07613327687675N/A65170400126517-040-0122026-03-19
07613327628357RPS88080000008808-000-0002025-10-01
07613327656763BPX79000120007900-012-0002026-03-04
07613327656770BPX79000130007900-013-0002026-03-04
07613327657760BPX79000340007900-034-0002026-03-04
07613327657777BPX79000150007900-015-0002026-03-04
07613327657784BPX79000310007900-031-0002026-03-04
07613327657791BPX79000990007900-099-0002026-03-04
07613327657807N/A79003760107900-376-0102026-03-04
07613327657814BPX79000370007900-037-0002026-03-04
07613327657821N/A79003770107900-377-0102026-03-04
07613327657838N/A79003780107900-378-0102026-03-04
07613327659429BPX79000250007900-025-0002026-03-04
37613327693288Malis6760-180-0106760-180-010-Z012026-02-25
37613327693295Malis6760-180-0056760-180-005-Z012026-02-25
37613327693363Malis6760-180-0156760-180-015-Z012026-02-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10884450413200StabiliT®Merit Medical Systems, Inc.NDN2026-03-11
10884450413217StabiliT®Merit Medical Systems, Inc.NDN2026-03-05
10884450587734StabiliT® Merit Medical Systems, Inc.NDN2026-02-19
10884450731700StabiliT®Merit Medical Systems, Inc.NDN2026-02-19
10884450731724StabiliT®Merit Medical Systems, Inc.NDN2026-02-19
10884450847296StabiliT®Merit Medical Systems, Inc.NDN2026-02-19
10884450847302StabiliT®Merit Medical Systems, Inc.NDN2026-02-19
10884450587772StabiliT®Merit Medical Systems, Inc.NDN2026-02-18
03701505801204DynamoTEKNIMEDNDN2026-02-02
03701505801211DynamoTEKNIMEDNDN2026-02-02
03701505801228DynamoTEKNIMEDNDN2026-02-02
03701505801235DynamoTEKNIMEDNDN2026-02-02
00197157026639ZAVATION ZVplasty Balloon CatheterZavation LLCNDN2025-07-08
00197157026646ZAVATION ZVplasty Balloon CatheterZavation LLCNDN2025-07-08
03701505801020PureKit Syringe 1.5cc MVTEKNIMEDNDN2025-03-31
03701505801037META+ System 1.5cc MVTEKNIMEDNDN2025-03-31
00815212026966OS 11G BONE FILLER KIT-OSTEOFIXIzi Medical Products, LLCNDN2025-03-26
00815212026942BKP-10-12.0-15.0-BIzi Medical Products, LLCNDN2025-01-08
00815212026959BKP-11-12.0-15.0-BIzi Medical Products, LLCNDN2025-01-08
00889095358230CONCORDGLOBUS MEDICAL, INC.NDN2024-12-01
00889095358247CONCORDGLOBUS MEDICAL, INC.NDN2024-12-01
00197157019334Zavation CURVED CURETTEZavation LLCNDN2024-11-13
00842166121546Zavation ZVplasty System AssemblyZavation LLCNDN2024-11-01
07613327638448OmnicurveSTRYKER CORPORATIONNDN2024-09-03
00815212026911KIT:BALLOON AND BONE FILLERIzi Medical Products, LLCNDN2024-08-28
00815212026928KIT:BALLOON,FILLER,ACCESS,DRILLIzi Medical Products, LLCNDN2024-08-28
10815212026895OsteoPearl Vertebral Balloon (15mm), 10GIzi Medical Products, LLCNDN2024-08-05
00815212026904OsteoPearl Vertebral Balloon (15mm) & Inflation Device Kit, 10GIzi Medical Products, LLCNDN2024-08-05
00197157019730ZavationZavation LLCNDN2024-07-01
00197157019747ZavationZavation LLCNDN2024-07-01