FDA.reportPublic FDA data

TRUMATCH

Primary DI
05420060381072
Brand
TRUMATCH
Company
Materialise NV
Model
SD980.107
Catalog number
SD980.107
Device description
TRUMATCH TI Implant - Mandible -small
Published
2018-10-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
JEYPlate, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JEYPlate, BoneDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173039000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173039000TruMatch CMF Titanium 3D Printed ImplantMaterialise NV2018-07-10JEY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05420060381072PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05420060381072054200603810725420060381072

GMDN Terms#

Term, Definition table
TermDefinition
Craniofacial fixation plate kit, non-bioabsorbableA collection of small sheets of firm material and bone screws, of various shapes/sizes, that are implanted onto fractured craniofacial bone (including the maxilla and/or mandible) to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals; the components are made of a material that is not chemically degraded or absorbed by natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Tools for implantation may be included. The device may also be used for craniofacial reconstructive procedures (e.g., to treat congenital malformations), endobrow fixation, or craniotomy flap fixation.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
373139427
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05404028001257SurgiCase PlannerSurgiCase Knee PlannerSurgiCase Knee Planner2026-05-28
05404028007006OrthoViewOrthoViewOrthoView2026-05-22
05404028001196Mimics Cardiac PlannerMimics Cardiac Planner TAVRMimics Cardiac Planner TAVR2026-05-15
05420060350856TruMatch CMF Titanium 3D Printed GuidesSD980.060SD980.0602026-04-29
05420060351631TruMatch CMF Titanium 3D Printed GuidesSD980.064SD980.0642026-04-29
05420060351648TruMatch CMF Titanium 3D Printed GuidesSD980.065SD980.0652026-04-29
05404028001202Mimics Automatic AlgorithmsMimics Automatic Algorithms CMF Orthognathic CT CBMimics Automatic Algorithms CMF Orthognathic CT CB2026-04-20
05404028001219Mimics Automatic Algorithms Mimics Automatic Algorithms CMF Reconstruction CT Mimics Automatic Algorithms CMF Reconstruction CT 2026-04-20
05404028001226Mimics Automatic Algorithms Mimics Automatic Algorithms Knee MRIMimics Automatic Algorithms Knee MRI2026-04-20
05404028001080Materialise Mimics Enlight CMFOrthognathic and Trauma PlannerOrthognathic and Trauma Planner2026-04-10
05404028001097Materialise Mimics Enlight CMFReconstruction PlannerReconstruction Planner2026-04-10
05404028001103Materialise Mimics Enlight CMFSplint DesignerSplint Designer2026-04-10
05404028001158Mimics FlowMimics FlowMimics Flow2026-03-23
05404028001172SurgiCase OnlineSurgiCase OnlineSurgiCase Online2026-03-23
05404028001189ProPlan CMF ProPlan CMF Online ProPlan CMF Online 2026-03-23
05404028000861Mimics Thoracic PlannerMimics Thoracic PlannerMimics Thoracic Planner2026-03-20
05420060360015BKS Total PSIKNM-OD01-00-01KNM-OD01-00-01 2022-09-21
05420060310027Zimmer Biomet Patient Specific InstrumentsKNM-ZB02-00-01KNM-ZB02-00-012018-08-11
05420060310034Zimmer Biomet Patient Specific InstrumentsKNM-ZB03-00-01KNM-ZB03-00-012018-08-11
05420060310041Zimmer Biomet Patient Specific InstrumentsKNM-ZB04-00-01KNM-ZB04-00-012018-08-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809233620106ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620113ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620120ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620137ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620144ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620151ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620168ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620182ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620199ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620205ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620298ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620304ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620311ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620335ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620342ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620366ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620380ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620397ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620403ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620410ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620427ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620489ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620502ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620526ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620533ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620540ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620557ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620625ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620632ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620649ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11