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
10887587078540NASD03.501.442SD035014422026-07-29
10886982362179NASD03.043.006SD030430062026-07-24
10887587078557NASD03.503.067SD035030672026-07-24
10887587078564NASD03.503.072SD035030722026-07-24
10705034712307NA03.604.002036040022016-12-31
10705034712802NA03.606.011036060112016-12-31
10705034714592NA03.613.012036130122016-12-31
10705034767819VentroFix304.8343048342016-12-31
10705034768939NA314.0643140642016-12-31
10705034768960Click'X314.0673140672016-12-31
10705034768977Click'X314.0683140682016-12-31
10705034768984Click'X314.0693140692016-12-31
10705034769646NA328.0263280262016-12-31
10705034772608NA388.3643883642016-12-31
10705034775401NA389.2883892882016-12-31
10705034777375NA394.5853945852016-12-31
20705034764051NA292.0202920202019-08-29
00863176000317FIBULINKFGS-1100FGS11002020-03-26
00863176000324FIBULINKFGS-1300FGS13002020-03-26
00863176000300FIBULINKFGS-1000FGS10002017-06-08

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Primary DI, Brand, Company table
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00810228570076CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-07-30
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00810228570090FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-07-30
07613327694482DELTAStryker Leibinger GmbH & Co. KGGXR2026-07-21
07613327694499DELTAStryker Leibinger GmbH & Co. KGGXR2026-07-21
00810125929892CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-07-13
00810125929908FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-07-13
00810125929915CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-07-13
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00810125929960CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-07-13
00810125929977CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-07-13
00810125929984CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-07-13
00810125929861CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-07-06
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00810125929823CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-06-24
00810125929830FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-06-24
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