FDA.reportPublic FDA data

MatrixNEURO

Primary DI
H98004503149S0
Brand
MatrixNEURO
Company
SYNTHES (U.S.A.) LP
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
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GXRCOVER, BURR HOLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
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
Multi-purpose surgical mesh, metallicA sterile flat woven/knitted material made of a biocompatible metal (e.g., surgical stainless steel, tantalum) with appropriate mechanical characteristics for implantation. This non-dedicated device is used alone or in combination with synthetic materials (e.g., polymers) 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). Disposable devices associated with implantation (e.g., introducer needles, trocars) may be included.

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
832637081
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705034718040NA03.620.219036202192018-10-29
10705034767802VentroFix304.8323048322016-12-31
10705034775418NA389.2963892962016-12-31
10705034775425NA389.2973892972016-12-31
10705034775432NA389.2983892982016-12-31
10705034775449NA389.2993892992016-12-31
10705034798455NA690.0386900382016-12-31
10887587039893NA338.7613387612016-12-31
10886982338778MAXFRAME1100022-011100022012024-02-05
10886982338570MAXFRAME1100011-011100011012022-04-26
10886982338587MAXFRAME1100010-011100010012022-04-26
10886982338594MAXFRAME1100012-011100012012022-04-26
10886982338600MAXFRAME1100007-011100007012022-04-26
10886982237217NA510.1615101612019-02-21
10887587039305NA329.37329372016-12-31
10705034741161NA04.616.135046161352015-09-14
10705034741178NA04.616.140046161402015-09-14
10705034741260NA04.616.185046161852015-09-14
10705034741284NA04.616.195046161952015-09-14
10886982027795NA02.007.000S02007000S2015-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327694482DELTAStryker Leibinger GmbH & Co. KGGXR2026-07-21
07613327694499DELTAStryker Leibinger GmbH & Co. KGGXR2026-07-21
08806390889049Leforte Neuro System Bone PlateJeil Medical CorporationGXR2023-11-30
G28436102NuCrani Large PlateNeurovention LLCGXR2022-06-21
08806390888851Leforte Neuro System Bone PlateJeil Medical CorporationGXR2022-05-03
07613327543032DELTAStryker Leibinger GmbH & Co. KGGXR2020-12-15
08809416061542Neuro Plating SystemOSTEONIC CO.,Ltd.GXR2019-02-14
08809416061559Neuro Plating SystemOSTEONIC CO.,Ltd.GXR2019-02-14
08809416061566Neuro Plating SystemOSTEONIC CO.,Ltd.GXR2019-02-14
08809416061573Neuro Plating SystemOSTEONIC CO.,Ltd.GXR2019-02-14
08809416061580Neuro Plating SystemOSTEONIC CO.,Ltd.GXR2019-02-14
08809416061603Neuro Plating SystemOSTEONIC CO.,Ltd.GXR2019-02-14
08809416061627Neuro Plating SystemOSTEONIC CO.,Ltd.GXR2019-02-14
08809416061634Neuro Plating SystemOSTEONIC CO.,Ltd.GXR2019-02-14
08809416061641Neuro Plating SystemOSTEONIC CO.,Ltd.GXR2019-02-14
08809416061658Neuro Plating SystemOSTEONIC CO.,Ltd.GXR2019-02-14
08809416061665Neuro Plating SystemOSTEONIC CO.,Ltd.GXR2019-02-14
08809416061672Neuro Plating SystemOSTEONIC CO.,Ltd.GXR2019-02-14
08809416061733Neuro Plating SystemOSTEONIC CO.,Ltd.GXR2019-02-14
08809399740946Neuro Plating SystemOSTEONIC CO.,Ltd.GXR2019-02-13
08809399740953Neuro Plating SystemOSTEONIC CO.,Ltd.GXR2019-02-13
08809399745231Neuro Plating SystemOSTEONIC CO.,Ltd.GXR2019-02-13
08809399745248Neuro Plating SystemOSTEONIC CO.,Ltd.GXR2019-02-13
08809399745255Neuro Plating SystemOSTEONIC CO.,Ltd.GXR2019-02-13
08809399745279Neuro Plating SystemOSTEONIC CO.,Ltd.GXR2019-02-13
08809399745286Neuro Plating SystemOSTEONIC CO.,Ltd.GXR2019-02-13
08809416061535Neuro Plating SystemOSTEONIC CO.,Ltd.GXR2019-02-13
08809416061689Neuro Plating SystemOSTEONIC CO.,Ltd.GXR2019-02-13
08809416061696Neuro Plating SystemOSTEONIC CO.,Ltd.GXR2019-02-13
08809416061702Neuro Plating SystemOSTEONIC CO.,Ltd.GXR2019-02-13