Home GUDID M572RBK0100800011 iDuo® iPoly™ Insert Kit
Primary DI M572RBK0100800011
Brand iDuo® iPoly™ Insert Kit
Company Conformis, Inc.
Model RBK010080001
Catalog number RBK0100800
Device description N/A
Published 2015-10-26
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name NPJ Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer OOG Knee Arthroplasty Implantation System
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NPJ Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic 2 OOG Knee Arthroplasty Implantation System Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status M572RBK0100800011 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Unicondylar knee insert A sterile implantable device designed to articulate the femoral and tibial components of a knee joint prosthesis during primary or revision unicompartmental knee joint replacement. It is a one-piece contoured device typically made of polyethylene (PE).
Device Sizes# Type, Value, Unit table Type Value Unit Height 8 Millimeter
Regulatory Flags# DUNS number 808821883 Device count 1 Serial number true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00810933031114 Cordera Hip System Offset Cup Impactor, Enztec 1080-646 1080-646 2022-03-07 00810933031183 Cordera Hip System Radel Liner Impactors 28mm 1080-655 1080-655 2022-03-07 00810933031190 Cordera Hip System Radel Liner Impactors 32mm 1080-656 1080-656 2022-03-07 00810933031206 Cordera Hip System Radel Liner Impactors 36mm 1080-657 1080-657 2022-03-07 00810933031213 Cordera Hip System Radel Liner Impactors 40mm 1080-658 1080-658 2022-03-07 00810933031220 Cordera Hip System T-handle Quick Connect 1080-659 1080-659 2022-03-07 00810933031237 Cordera Hip System OrthoGroup Cup Impactor 1080-660 1080-660 2022-03-07 00850268007187 iTotal® Impactor Head 1080-541 2016-10-24 00850268007194 iTotal® Impactor Head 1080-535 2016-10-24 00850268007200 iTotal® CR Tibial Tray Impactor Tip 1080-536 2016-10-24 00850268007217 iTotal® PS Tibial Tray Impactor Tip 1080-542 2016-10-24 00850268007224 iTotal® Poly Impactor Tip 1080-524 2016-10-24 M572HDL060C24S011 iTotal® Hip Replacement System HDL060C24S01 HDL060C24S 2018-08-06 M572HDL060D24S011 iTotal® Hip Replacement System HDL060D24S01 HDL060D24S 2018-07-30 M572HDL060D34S011 iTotal® Hip Replacement System HDL060D34S01 HDL060D34S 2018-08-06 M572HDL060E24S011 iTotal® Hip Replacement System HDL060E24S01 HDL060E24S 2018-08-06 M572HDL060E34S011 iTotal® Hip Replacement System HDL060E34S01 HDL060E34S 2018-08-06 M572HDL060F24S011 iTotal® Hip Replacement System HDL060F24S01 HDL060F24S 2018-08-06 M572HDL060F34S011 iTotal® Hip Replacement System HDL060F34S01 HDL060F34S 2018-08-06 M572HDL060C10S011 iTotal® Hip Replacement System HDL060C10S01 HDL060C10S 2018-08-06
Other Devices Sharing Product Codes# 
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