FDA.reportPublic FDA data

TRUMATCH

Primary DI
05420060381065
Brand
TRUMATCH
Company
Materialise NV
Model
SD980.106
Catalog number
SD980.106
Device description
TRUMATCH TI Implant - Midface 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
05420060381065PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05420060381065054200603810655420060381065

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
05404028001394SurgiCase Shoulder PlannerSurgiCase Shoulder PlannerSurgiCase Shoulder Planner2026-11-03
05404028001370Mimics Cardiac PlannerMimics Cardiac Planner TAVRMimics Cardiac Planner TAVR2026-10-30
05420060351235TRUMATCHSD980.041SD980.0412026-10-22
05420060351242TRUMATCHSD980.042SD980.0422026-10-22
05420060351259TRUMATCHSD980.043SD980.0432026-10-22
05420060351266TRUMATCHSD980.044SD980.0442026-10-22
05420060351273TRUMATCHSD980.045SD980.0452026-10-22
05420060351280TRUMATCHSD980.046SD980.0462026-10-22
05420060351297TRUMATCHSD980.047SD980.0472026-10-22
05420060351303TRUMATCHSD980.048SD980.0482026-10-22
05420060351310TRUMATCHSD980.049SD980.0492026-10-22
05420060351327TRUMATCHSD980.050SD980.0502026-10-22
05420060351334TRUMATCHSD980.051SD980.0512026-10-22
05420060351341TRUMATCHSD980.052SD980.0522026-10-22
05420060351358TRUMATCHSD980.053SD980.0532026-10-22
05420060351365TRUMATCHSD980.054SD980.0542026-10-22
05420060351372TRUMATCHSD980.055SD980.0552026-10-22
05420060351389TRUMATCHSD980.056SD980.0562026-10-22
05420060351396TRUMATCHSD980.057SD980.0572026-10-22
05420060351402TRUMATCHSD980.058SD980.0582026-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05420060351235TRUMATCHMaterialise NVJEY2026-10-22
05420060351242TRUMATCHMaterialise NVJEY2026-10-22
05420060351259TRUMATCHMaterialise NVJEY2026-10-22
05420060351266TRUMATCHMaterialise NVJEY2026-10-22
05420060351273TRUMATCHMaterialise NVJEY2026-10-22
05420060351280TRUMATCHMaterialise NVJEY2026-10-22
05420060351297TRUMATCHMaterialise NVJEY2026-10-22
05420060351303TRUMATCHMaterialise NVJEY2026-10-22
05420060351310TRUMATCHMaterialise NVJEY2026-10-22
05420060351327TRUMATCHMaterialise NVJEY2026-10-22
05420060351334TRUMATCHMaterialise NVJEY2026-10-22
05420060351341TRUMATCHMaterialise NVJEY2026-10-22
05420060351358TRUMATCHMaterialise NVJEY2026-10-22
05420060351365TRUMATCHMaterialise NVJEY2026-10-22
05420060351372TRUMATCHMaterialise NVJEY2026-10-22
05420060351389TRUMATCHMaterialise NVJEY2026-10-22
05420060351396TRUMATCHMaterialise NVJEY2026-10-22
05420060351402TRUMATCHMaterialise NVJEY2026-10-22
00888118150288LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-10-21
00888118150295LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-10-21
00888118150301LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-10-21
00888118150318LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-10-21
00888118150325LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-10-21
00888118150332LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-10-21
00888118150349LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-10-21
00888118150356LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-10-21
00888118150363LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-10-21
00888118150370LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-10-21
00888118150387LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-10-21
00888118150394LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-10-21