FDA.reportPublic FDA data

MatrixMANDIBLE

Primary DI
10887587021638
Brand
MatrixMANDIBLE
Company
Synthes GmbH
Model
04.503.555.01
Catalog number
0450355501
Device description
2.0MM TI MATRIXMANDIBLE SCREW FINE PITCH / 5MM
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
JEYPLATE, BONE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JEYPlate, BoneDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121574000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121574000SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEMSynthes, Inc.2012-06-29JEY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10887587021638PrimaryGS10
H98004503555010SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088758702163810887587021638

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
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705034753690ChronOS07.801.100.99S0780110099S2015-09-14
10705034753706ChronOS07.801.101.99S0780110199S2015-09-14
10705034753713ChronOS07.801.110.99S0780111099S2015-09-14
10705034753720ChronOS07.801.111.99S0780111199S2015-09-14
10705034753737ChronOS07.801.200.99S0780120099S2015-09-14
10705034799933ChronOS710.002.99S71000299S2015-09-14
10705034799940ChronOS710.014.99S71001499S2015-09-14
10705034799957ChronOS710.019.99S71001999S2015-09-14
10705034799964ChronOS710.021.99S71002199S2015-09-14
10705034799971ChronOS710.025.99S71002599S2015-09-14
10705034799988ChronOS710.026.99S71002699S2015-09-14
10705034799995ChronOS710.027.99S71002799S2015-09-14
10705034800004ChronOS710.038.99S71003899S2015-09-14
10705034800011ChronOS710.039.99S71003999S2015-09-14
10705034800059ChronOS710.921.99S71092199S2015-09-14
10705034800066ChronOS710.922.99S71092299S2015-09-14
10705034800073ChronOS710.923.99S71092399S2015-09-14
10705034800080ChronOS710.924.99S71092499S2015-09-14
10705034800097ChronOS710.925.99S71092599S2015-09-14
10705034800103ChronOS710.926.99S71092699S2015-09-14

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00888118155528IPSKLS-Martin L.P.JEY2026-09-28
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00888118155559IPSKLS-Martin L.P.JEY2026-09-28
00888118155566IPSKLS-Martin L.P.JEY2026-09-28
07613327711578NAStryker Leibinger GmbH & Co. KGJEY2026-09-24
07613327711585NAStryker Leibinger GmbH & Co. KGJEY2026-09-24
07613327711592NAStryker Leibinger GmbH & Co. KGJEY2026-09-24
07613327711608NAStryker Leibinger GmbH & Co. KGJEY2026-09-24
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04046826531454MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJEY2026-07-28
00888118154620LEVEL ONE CMFKLS-Martin L.P.JEY2026-07-21
00888118154637LEVEL ONE CMFKLS-Martin L.P.JEY2026-07-21
07613327694482DELTAStryker Leibinger GmbH & Co. KGJEY2026-07-21
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04046826346812MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJEY2026-06-25
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