FDA.reportPublic FDA data

MatrixNEURO

Primary DI
10887587018652
Brand
MatrixNEURO
Company
Synthes GmbH
Model
04.503.149S
Catalog number
04503149S
Device description
TI MATRIXNEURO RECON MESH 70MM DIA/GOLD-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
GXRCOVER, BURR HOLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWOPlate, Cranioplasty, Preformed, AlterableNeurology2
GXRCover, Burr HoleNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123723000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123723000SYNTHES MATRIXNEURO CRANIAL PLATING SYSTEMSynthes2013-09-05GWO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10887587018652PrimaryGS10
H98004503149S0SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088758701865210887587018652

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
08806390889049Leforte Neuro System Bone PlateJeil Medical CorporationGXR2023-11-30
G28436102NuCrani Large PlateNeurovention LLCGXR2022-06-21
G28440901KTC Burr Hole CoverNeurovention LLCGWO2022-06-21
G28441001KTC Burr Hole CoverNeurovention LLCGWO2022-06-21
08806390888851Leforte Neuro System Bone PlateJeil Medical CorporationGWO2022-05-03
08806390888851Leforte Neuro System Bone PlateJeil Medical CorporationGXR2022-05-03
07613327543032DELTAStryker Leibinger GmbH & Co. KGGXR2020-12-15
07613327423648DELTAStryker Leibinger GmbH & Co. KGGXR2018-05-22
07613327423655DELTAStryker Leibinger GmbH & Co. KGGXR2018-05-22
07613327423679DELTAStryker Leibinger GmbH & Co. KGGXR2018-05-22
08806390869539Leforte Neuro System Bone PlateJeil Medical CorporationGXR2018-05-17
08806390869546Leforte Neuro System Bone PlateJeil Medical CorporationGXR2018-05-17
08806390869553Leforte Neuro System Bone PlateJeil Medical CorporationGXR2018-05-17
08806390869560Leforte Neuro System Bone PlateJeil Medical CorporationGXR2018-05-17
08806390869577Leforte Neuro System Bone PlateJeil Medical CorporationGXR2018-05-17
07613327177527DELTAStryker Leibinger GmbH & Co. KGGXR2018-04-16
07613327177534DELTAStryker Leibinger GmbH & Co. KGGXR2018-04-16
08809265151982Leforte Neuro System Bone PlateJeil Medical CorporationGWO2018-04-12
08809265151982Leforte Neuro System Bone PlateJeil Medical CorporationGXR2018-04-12
08806390862271Leforte Neuro System Bone PlateJeil Medical CorporationGWO2018-02-26
08806390862271Leforte Neuro System Bone PlateJeil Medical CorporationGXR2018-02-26
08806390861953Leforte Neuro System Bone PlateJeil Medical CorporationGWO2018-01-22
08806390861953Leforte Neuro System Bone PlateJeil Medical CorporationGXR2018-01-22