Home GUDID E31442422751 Signature
Primary DI E31442422751
Brand Signature
Company Materialise NV
Model 42-422751
Catalog number 42-422751
Device description SIG C/T TKA GDE/MDL SET 03-05
Published 2016-09-24
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive OOG Knee Arthroplasty Implantation System
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer Orthopedic 2 JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic 2 MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic 2 OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive Orthopedic 2 OOG Knee Arthroplasty Implantation System Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status E31442422751 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Custom-made organ/bone anatomy model/surgical guide kit A 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"", ""Hydrogen Peroxide""]" Moist Heat or Steam Sterilization;Hydrogen Peroxide
Regulatory Flags# DUNS number 373139427 Device count 1 Lot or batch true Expiration date on label true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 05404028001257 SurgiCase Planner SurgiCase Knee Planner SurgiCase Knee Planner 2026-05-28 05404028007006 OrthoView OrthoView OrthoView 2026-05-22 05404028001196 Mimics Cardiac Planner Mimics Cardiac Planner TAVR Mimics Cardiac Planner TAVR 2026-05-15 05420060350856 TruMatch CMF Titanium 3D Printed Guides SD980.060 SD980.060 2026-04-29 05420060351631 TruMatch CMF Titanium 3D Printed Guides SD980.064 SD980.064 2026-04-29 05420060351648 TruMatch CMF Titanium 3D Printed Guides SD980.065 SD980.065 2026-04-29 05404028001202 Mimics Automatic Algorithms Mimics Automatic Algorithms CMF Orthognathic CT CB Mimics Automatic Algorithms CMF Orthognathic CT CB 2026-04-20 05404028001219 Mimics Automatic Algorithms Mimics Automatic Algorithms CMF Reconstruction CT Mimics Automatic Algorithms CMF Reconstruction CT 2026-04-20 05404028001226 Mimics Automatic Algorithms Mimics Automatic Algorithms Knee MRI Mimics Automatic Algorithms Knee MRI 2026-04-20 05404028001080 Materialise Mimics Enlight CMF Orthognathic and Trauma Planner Orthognathic and Trauma Planner 2026-04-10 05404028001097 Materialise Mimics Enlight CMF Reconstruction Planner Reconstruction Planner 2026-04-10 05404028001103 Materialise Mimics Enlight CMF Splint Designer Splint Designer 2026-04-10 05404028001158 Mimics Flow Mimics Flow Mimics Flow 2026-03-23 05404028001172 SurgiCase Online SurgiCase Online SurgiCase Online 2026-03-23 05404028001189 ProPlan CMF ProPlan CMF Online ProPlan CMF Online 2026-03-23 05404028000861 Mimics Thoracic Planner Mimics Thoracic Planner Mimics Thoracic Planner 2026-03-20 05420060360015 BKS Total PSI KNM-OD01-00-01 KNM-OD01-00-01 2022-09-21 05420060310027 Zimmer Biomet Patient Specific Instruments KNM-ZB02-00-01 KNM-ZB02-00-01 2018-08-11 05420060310034 Zimmer Biomet Patient Specific Instruments KNM-ZB03-00-01 KNM-ZB03-00-01 2018-08-11 05420060310041 Zimmer Biomet Patient Specific Instruments KNM-ZB04-00-01 KNM-ZB04-00-01 2018-08-11
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