FDA.reportPublic FDA data

MatrixNEURO

Primary DI
10887587018546
Brand
MatrixNEURO
Company
Synthes GmbH
Model
04.503.126
Catalog number
04503126
Device description
TI MATRIXNEURO CONTOUR MESH 70MM DIA/0.6MM RIGID
Published
2015-09-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GWOPlate, cranioplasty, preformed, alterable
GXRCOVER, BURR HOLE
JEYPLATE, BONE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWOPlate, Cranioplasty, Preformed, AlterableNeurology2
GXRCover, Burr HoleNeurology2
JEYPlate, BoneDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K042365000
K123723000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K042365000SYNTHES (USA) NEURO PLATE AND SCREW SYSTEMSynthes (Usa)2004-11-18JEY
K123723000SYNTHES MATRIXNEURO CRANIAL PLATING SYSTEMSynthes2013-09-05GWO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10887587018546PrimaryGS10
H980045031260SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088758701854610887587018546

GMDN Terms#

Term, Definition table
TermDefinition
Craniofacial fixation plate, non-bioabsorbable, non-customizedA small, implantable, non-customized sheet of firm material designed to be attached with screws to craniofacial bone (including the maxilla and/or mandible) to bridge and stabilize a fracture gap or craniotomy flap, cover a burr hole and/or position/stabilize a prosthesis. It is made of non-bioabsorbable materials (e.g., surgical steel, titanium alloy) and is available in a variety of designs (e.g., Y-plate, curved plate, mesh-panel, burr hole cover). Instruments intended to facilitate implantation (e.g., driver), or plate fixation implants (i.e., bone screws), may be packaged with the plate.

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
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810112596793TriLEAP04.900.151049001512026-02-19
00810112597202TriLEAP04.913.035049130352026-02-19
00810112597219TriLEAP04.913.040049130402026-02-19
00810112597226TriLEAP04.913.045049130452026-02-19
00810112597233TriLEAP04.913.050049130502026-02-19
00810112597240TriLEAP04.913.055049130552026-02-19
00810112597257TriLEAP04.913.060049130602026-02-19
00810112597264TriLEAP04.913.065049130652026-02-19
00810112597271TriLEAP04.914.035049140352026-02-19
00810112597288TriLEAP04.914.040049140402026-02-19
00810112597295TriLEAP04.914.050049140502026-02-19
00810112597301TriLEAP04.914.045049140452026-02-19
00810112597318TriLEAP04.914.055049140552026-02-19
00810112597325TriLEAP04.914.060049140602026-02-19
00810112597332TriLEAP04.914.065049140652026-02-19
00810112598933TriLEAP04.900.118049001182026-02-19
00810112598940TriLEAP04.900.119049001192026-02-19
00810112598957TriLEAP04.900.120049001202026-02-19
00810112598964TriLEAP04.900.121049001212026-02-19
00810112598971TriLEAP04.900.122049001222026-02-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810228570618FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-10-22
00810228570625FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-10-22
00810228570632CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-10-22
05420060351235TRUMATCHMaterialise NVJEY2026-10-22
05420060351242TRUMATCHMaterialise NVJEY2026-10-22
05420060351259TRUMATCHMaterialise NVJEY2026-10-22
05420060351266TRUMATCHMaterialise NVJEY2026-10-22
05420060351273TRUMATCHMaterialise NVJEY2026-10-22
05420060351280TRUMATCHMaterialise NVJEY2026-10-22
05420060351297TRUMATCHMaterialise NVJEY2026-10-22
05420060351303TRUMATCHMaterialise NVJEY2026-10-22
05420060351310TRUMATCHMaterialise NVJEY2026-10-22
05420060351327TRUMATCHMaterialise NVJEY2026-10-22
05420060351334TRUMATCHMaterialise NVJEY2026-10-22
05420060351341TRUMATCHMaterialise NVJEY2026-10-22
05420060351358TRUMATCHMaterialise NVJEY2026-10-22
05420060351365TRUMATCHMaterialise NVJEY2026-10-22
05420060351372TRUMATCHMaterialise NVJEY2026-10-22
05420060351389TRUMATCHMaterialise NVJEY2026-10-22
05420060351396TRUMATCHMaterialise NVJEY2026-10-22
05420060351402TRUMATCHMaterialise NVJEY2026-10-22
00888118150288LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-10-21
00888118150295LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-10-21
00888118150301LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-10-21
00888118150318LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-10-21
00888118150325LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-10-21
00888118150332LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-10-21
00888118150349LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-10-21
00888118150356LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-10-21
00888118150363LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-10-21