FDA.reportPublic FDA data

MatrixRIB

Primary DI
20887587017324
Brand
MatrixRIB
Company
Synthes GmbH
Model
04.501.042.05
Catalog number
0450104205
Device description
2.9MM TI MATRIXRIB NON-LOCKING SCREW/SELF-TAPPING/12MM
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
HRSPLATE, FIXATION, BONE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K081623000
K133616000
K161590000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081623000SYNTHES RIB FIXATION SYSTEMSynthes (Usa)2008-09-08HRS
K133616000MATRIXRIB FIXATION SYSTEMSynthes (USA) Products, LLC2014-05-02HRS
K161590000MatrixRIB Fixation SystemSynthes (USA) Products, LLC2016-11-03HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20887587017324PrimaryGS10
H98004501042050SecondaryHIBCC0
80887587017326Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088758701732420887587017324
8088758701732680887587017326

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw (non-sliding)A small, threaded, non-bioabsorbable, implantable rod intended for internal orthopaedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone, or to provide direct interfragmentary stabilization of a fractured bone; it is not intended to be introduced through the sleeve of a femoral neck fixation plate/sleeve, not used in dentistry/orthodontics, craniofacial or spinal bones, and not dedicated to intramedullary fixation/arthrodesis. It is typically of cortical or cancellous design and has a drive (e.g., slot, cross, star, polygonal) at its proximal end for introduction with a screwdriver.

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
5
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
10886982113078NA04.130.260S04130260S2016-03-15
10886982077868NA03.311.010033110102015-09-14
10886982077875NA03.311.011033110112015-09-14
10886982077882NA03.311.012033110122015-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08904255300873ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-20
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08904255300897ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-20
08904255300903ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-20
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08904255300927ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-20
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08904255300941ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-20
08904255301634ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-20
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08904255301672ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-20
08904255301689ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-20
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08904255301719ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-20
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08904255301931ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-20
08904255301948ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-20
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08904255301986ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-20
08904255301993ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-20
08904255302006ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-20
08904255302013ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-20
08904255302020ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-20
08904255302037ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-20