FDA.reportPublic FDA data

MatrixNEURO

Primary DI
10887587066547
Brand
MatrixNEURO
Company
Synthes GmbH
Model
04.503.157S
Catalog number
04503157S
Device description
TI MATRIXNEURO PREFORMED MESH 109MM X 78MM FRONTAL-STERILE
Published
2015-09-14
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
GWOPlate, cranioplasty, preformed, alterable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWOPlate, Cranioplasty, Preformed, AlterableNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140462000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140462000MATRIXNEURO PREFORMED MESH (PART OF THE MATRIXNEURO CRANIAL PLATING SYSTEM)Synthes (USA) Products, LLC2014-06-13GWO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10887587066547PrimaryGS10
H98004503157S0SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088758706654710887587066547

GMDN Terms#

Term, Definition table
TermDefinition
Extra-gynaecological surgical mesh, metalA non-bioabsorbable, implantable material (e.g., flat sheet) made from made from a biocompatible metal, with appropriate mechanical characteristics for implantation, intended for an extra-gynaecological tissue repair/reinforcement application(s) to support or protect tissues in reconstructive surgical procedures (e.g., to repair large chest wall defects or large abdominal incisional hernias) and/or orthopaedic procedures (e.g., cranioplasty, femoral reconstruction); it is not primarily intended for dental use. Disposable devices associated with implantation may be supplied with the mesh.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
486711679
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886982030054LCP02.108.412021084122015-09-14
10886982033079VA-LCP02.112.049021120492015-09-14
10886982042590LCP02.124.213021242132015-09-14
10886982055552NA02.221.002S02221002S2015-09-14
10886982055569NA02.221.003S02221003S2015-09-14
10886982055583NA02.221.004S02221004S2015-09-14
10886982076748NA03.221.015032210152016-12-31
10886982076762NA03.221.016032210162016-12-31
10886982076779NA03.221.017032210172016-12-31
10886982120960NA04.221.002S04221002S2015-09-14
10886982120977NA04.221.003S04221003S2015-09-14
10886982120991NA04.221.004S04221004S2015-09-14
10886982182494NA298.800.01S29880001S2015-09-14
10886982182500NA298.801.01S29880101S2015-09-14
10886982198112NA391.1033911032016-12-31
10886982198129NA391.1043911042016-12-31
10886982198136NA391.1053911052016-12-31
10886982198143NA391.1063911062016-12-31
10886982198150NA391.1073911072016-12-31
10886982198167NA391.1083911082016-12-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810125929663CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-06-02
00810125929670FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-06-02
00810125929625CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-06-01
00810125929632CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-06-01
00810125929649CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-06-01
00810125929656CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-06-01
08806390889049Leforte Neuro System Bone PlateJeil Medical CorporationGWO2023-11-30
G28440901KTC Burr Hole CoverNeurovention LLCGWO2022-06-21
G28441001KTC Burr Hole CoverNeurovention LLCGWO2022-06-21
08806390888851Leforte Neuro System Bone PlateJeil Medical CorporationGWO2022-05-03
09349797002547StarPoreANATOMICS PTY LTDGWO2020-04-03
09349797002561StarPoreANATOMICS PTY LTDGWO2020-04-03
09349797000208StarPoreANATOMICS PTY LTDGWO2020-01-08
09349797000222StarPoreANATOMICS PTY LTDGWO2020-01-08
08809595972844Neuro Plating SystemOSTEONIC CO.,Ltd.GWO2019-12-30
08809595972851Neuro Plating SystemOSTEONIC CO.,Ltd.GWO2019-12-30
08809595972875Neuro Plating SystemOSTEONIC CO.,Ltd.GWO2019-12-30
08809595972899Neuro Plating SystemOSTEONIC CO.,Ltd.GWO2019-12-30
08809416061542Neuro Plating SystemOSTEONIC CO.,Ltd.GWO2019-02-14
08809416061559Neuro Plating SystemOSTEONIC CO.,Ltd.GWO2019-02-14
08809416061566Neuro Plating SystemOSTEONIC CO.,Ltd.GWO2019-02-14
08809416061573Neuro Plating SystemOSTEONIC CO.,Ltd.GWO2019-02-14
08809416061580Neuro Plating SystemOSTEONIC CO.,Ltd.GWO2019-02-14
08809416061603Neuro Plating SystemOSTEONIC CO.,Ltd.GWO2019-02-14
08809416061627Neuro Plating SystemOSTEONIC CO.,Ltd.GWO2019-02-14
08809416061634Neuro Plating SystemOSTEONIC CO.,Ltd.GWO2019-02-14
08809416061641Neuro Plating SystemOSTEONIC CO.,Ltd.GWO2019-02-14
08809416061658Neuro Plating SystemOSTEONIC CO.,Ltd.GWO2019-02-14
08809416061665Neuro Plating SystemOSTEONIC CO.,Ltd.GWO2019-02-14
08809416061672Neuro Plating SystemOSTEONIC CO.,Ltd.GWO2019-02-14