FDA.reportPublic FDA data

ProPlan CMF

Primary DI
05420060350016
Brand
ProPlan CMF
Company
Materialise NV
Model
SD900.001
Catalog number
SD900.001
Device description
Patient Specific Instrument and Planning Kit, Mandible Reconstruction
Published
2016-09-13
Public version status
Update
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
K103136000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103136000SURGICASE CMF, SURGICASE CONNECT, SURGICASE GUIDEMaterialise NV2011-03-18JEY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05420060350016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05420060350016054200603500165420060350016

GMDN Terms#

Term, Definition table
TermDefinition
Custom-made organ/bone anatomy model/surgical guide kitA collection of custom-made devices intended to be used to assist anatomical visualization, surgical treatment planning, and intraoperative surgical procedures (e.g., orientation of implant components, guiding of surgical instruments). It consists of an anatomy model(s) of an organ/bone and an orthopaedic/craniomaxillofacial surgical guide(s) [e.g., for osteotomy, arthroplasty]; it is made of synthetic polymer materials and is manufactured by 3-D printing and CAD/CAM techniques to match the patient-specific contours of the target anatomical site. This is a single-use device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
373139427
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
05420060380747TRUMATCHSD980.028SD980.0282025-02-28
05420060363191TruMatch Personalised Solutions Shoulder System2255010032255010032022-03-11
E314KNMLM010101Lima PSIKNM-LM01-01-01KNM-LM01-01-012016-12-01
E314KNMLM0101010Lima PSIKNM-LM01-01-01KNM-LM01-01-012017-07-21
E314KNMLM010201Lima PSIKNM-LM01-02-01KNM-LM01-02-012016-12-01
E314KNMLM0102010Lima PSIKNM-LM01-02-01KNM-LM01-02-012017-07-21
E314KNMLM020001Lima PSIKNM-LM02-00-01KNM-LM02-00-012016-12-01
E314KNMLM0200010Lima PSIKNM-LM02-00-01KNM-LM02-00-012017-07-21
E314SHCLM010101Lima PSISHC-LM01-01-01SHC-LM01-01-012016-12-01
E314SHCLM0101010Lima PSISHC-LM01-01-01SHC-LM01-01-012017-07-21
E314SHCLM020101Lima PSISHC-LM02-01-01SHC-LM02-01-012016-12-01
E314SHCLM0201010Lima PSISHC-LM02-01-01SHC-LM02-01-012017-07-21
05420060381041TruMatchSD980.104SD980.1042020-03-16
05420060351013ProPlan CMFSD900.101SD900.1012016-09-13
05420060351020ProPlan CMFSD900.102SD900.1022016-09-13
05420060351044ProPlan CMFSD900.104SD900.1042016-09-13
05420060351051ProPlan CMFSD900.105SD900.1052016-09-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04046826486228MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJEY2026-07-29
04046826531478MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJEY2026-07-29
04046826531485MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJEY2026-07-29
04046826561741MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJEY2026-07-29
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
07613327694499DELTAStryker Leibinger GmbH & Co. KGJEY2026-07-21
04046826346812MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJEY2026-06-25
04046826416676MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJEY2026-06-25
04046826542337MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJEY2026-06-25
04046826543655MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJEY2026-06-25
04046826552473MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJEY2026-06-25
00888118126528LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2020-04-22
05420060381041TruMatchMaterialise NVJEY2020-03-16
10888118113600LEVEL ONE CMFKLS-Martin L.P.JEY2017-10-20
10888118113617LEVEL ONE CMFKLS-Martin L.P.JEY2017-10-20
05420060380150TruMatchMaterialise NVJEY2017-08-31
05420060380174TruMatchMaterialise NVJEY2017-08-31
05420060381034TruMatchMaterialise NVJEY2017-08-31
05420060351112ProPlan CMFMaterialise NVJEY2016-09-15
05420060351013ProPlan CMFMaterialise NVJEY2016-09-13
05420060351020ProPlan CMFMaterialise NVJEY2016-09-13
05420060351044ProPlan CMFMaterialise NVJEY2016-09-13
05420060351051ProPlan CMFMaterialise NVJEY2016-09-13
05420060351068ProPlan CMFMaterialise NVJEY2016-09-13
05420060351075ProPlan CMFMaterialise NVJEY2016-09-13
00888118001825LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24
00888118001870LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24