FDA.reportPublic FDA data

TruMatch CMF Titanium 3D Printed Guides

Primary DI
05420060351648
Brand
TruMatch CMF Titanium 3D Printed Guides
Company
Materialise NV
Model
SD980.065
Catalog number
SD980.065
Device description
Titanium 3D Printed Guide for Frontal Bone, Type 2
Published
2026-04-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
PPTCranial Surgical Planning And Instrument Guides

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PPTCranial Surgical Planning And Instrument GuidesNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K253308000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253308000Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic ModelsMaterialise NV2026-01-07PPT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05420060351648PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05420060351648054200603516485420060351648

GMDN Terms#

Term, Definition table
TermDefinition
Custom-made orthopaedic/craniofacial surgical guideA custom-made surgical instrument intended to be used in an orthopaedic and/or craniomaxillofacial procedure (e.g., osteotomy, arthroplasty, tumour resection, distraction osteogenesis, cranial vault reconstruction) to assist in the intraoperative orientation of implant components, outlining the desired cut-line, and/or guiding of surgical instruments (e.g., surgical drill, oscillating cutting saw). It is typically 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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
373139427
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
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
05420060351068ProPlan CMFSD900.106SD900.1062016-09-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05420060350856TruMatch CMF Titanium 3D Printed GuidesMaterialise NVPPT2026-04-29
05420060351631TruMatch CMF Titanium 3D Printed GuidesMaterialise NVPPT2026-04-29
00888118144683IPSKLS-Martin L.P.PPT2024-10-08
00888118144720IPSKLS-Martin L.P.PPT2024-10-08
00888118140999IPSKLS-Martin L.P.PPT2023-03-22
00888118141002IPSKLS-Martin L.P.PPT2023-03-22
00888118141019IPSKLS-Martin L.P.PPT2023-03-22
00888118141026IPSKLS-Martin L.P.PPT2023-03-22
00888118141071IPSKLS-Martin L.P.PPT2023-03-22
00888118141088IPSKLS-Martin L.P.PPT2023-03-22
00888118141125IPSKLS-Martin L.P.PPT2023-03-22
00888118141163IPSKLS-Martin L.P.PPT2023-03-22
00888118141408IPSKLS-Martin L.P.PPT2023-03-22
00888118136190IPSKLS-Martin L.P.PPT2022-11-25
00888118136718IPSKLS-Martin L.P.PPT2022-11-25
00888118136725IPSKLS-Martin L.P.PPT2022-11-25
00888118136732IPSKLS-Martin L.P.PPT2022-11-25
00888118129260IPSKLS-Martin L.P.PPT2020-12-22
00888118129307IPSKLS-Martin L.P.PPT2020-12-22
00888118128867IPSKLS-Martin L.P.PPT2020-09-21
00888118128898IPSKLS-Martin L.P.PPT2020-09-21
00888118122681IPSKLS-Martin L.P.PPT2019-09-20
00888118122698IPSKLS-Martin L.P.PPT2019-09-20
00888118122704IPSKLS-Martin L.P.PPT2019-09-20
00888118122711IPSKLS-Martin L.P.PPT2019-09-20
00888118122728IPSKLS-Martin L.P.PPT2019-09-20
00888118122735IPSKLS-Martin L.P.PPT2019-09-20
00888118099952IPSKLS-Martin L.P.PPT2018-10-24
00816847021425VSP Cranial3D SYSTEMS, INC.PPT2016-10-12
00816847021432VSP Cranial3D SYSTEMS, INC.PPT2016-10-12