Home GUDID M572UKA1111111031 iUni iPoly Implant
Primary DI M572UKA1111111031
Brand iUni iPoly Implant
Company Conformis, Inc.
Model UKA-111-111103
Catalog number UKA-111-1111
Device description IUNI–IPOLY–IMPLANT KIT–RIGHT or Left LATERAL or medial
Published 2022-08-16
Public version status New
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 HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer OOG Knee Arthroplasty Implantation System
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer Orthopedic 2 OOG Knee Arthroplasty Implantation System Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status M572UKA1111111031 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Unicondylar knee prosthesis A sterile artificial substitute for the bearing surface of only one femoral condyle and corresponding tibial condyle of the knee (medial or lateral condyle) implanted during primary or revision knee replacement. It typically consists of femoral and tibial components and a knee insert which are made of metal or polyethylene (PE); fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement. The device is indicated in unicompartmental disease and/or damage (e.g., from arthritis) to the bearing surfaces of the knee.
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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