FDA.reportPublic FDA data

MatrixNEURO

Primary DI
20887587018345
Brand
MatrixNEURO
Company
Synthes GmbH
Model
04.503.104.20
Catalog number
0450310420
Device description
TI MATRIXNEURO SCREW SELF-DRILLING 4MM
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
20887587018345PrimaryGS10
H98004503104200SecondaryHIBCC0
80887587018347Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088758701834520887587018345
8088758701834780887587018347

GMDN Terms#

Term, Definition table
TermDefinition
Craniofacial bone screw, non-bioabsorbableA small, threaded rod with a slotted and/or polygonal (e.g., hexagonal) head intended to be implanted in craniofacial bone (including the maxilla and/or mandible) for fracture fixation by direct interfragmentary stabilization of bone or by screwing plates in place; it may also be intended for transplanted bone fixation. It may be self-drilling/self-tapping and is made of a material that is not chemically degraded or absorbed via natural body processes [e.g., implant grade metal such as titanium (Ti)]. Its uses include repair of orbital fractures and fractures around the cranial sinuses, paediatric reconstructive surgery, craniotomy flap fixation, bone augmentation procedures.

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
20
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886982239297NA519.51519512017-02-20
10886982195937NA357.2223572222017-02-20
10886982238115NA511.9045119042016-12-31
10886982239358NA519.53519532016-12-31
10886982249043NA60.550.011605500112017-02-20
10886982249104NA60.550.016605500162017-02-20
10886982249135NA60.550.020605500202017-02-20
10886982249142NA60.550.021605500212017-02-20
10886982254917NA690.5946905942017-02-20
10886982362797NASD03.111.915SD031119152026-08-26
10886982362803NASD03.111.916SD031119162026-08-26
10886982362810NASD03.111.917SD031119172026-08-26
10886982362827NASD03.111.918SD031119182026-08-26
10886982362834NASD03.111.919SD031119192026-08-26
10886982362988NASD312.030SD3120302026-08-26
10886982362995NASD312.031SD3120312026-08-26
10886982363008NASD312.032SD3120322026-08-26
10886982363015NASD312.033SD3120332026-08-26
10887587078496NASD03.503.037SD035030372026-08-26
10887587078595NASD03.501.444SD035014442026-08-26

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Primary DI, Brand, Company table
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