Home GUDID 04719872153733 """UNITED"" USTAR II Knee System"
Primary DI 04719872153733
Brand """UNITED"" USTAR II Knee System"
Company UNITED ORTHOPEDIC CORP.
Model 2715-1015
Device description Cemented straight stem, RHS, Ø15×100mm
Published 2020-02-24
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 KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer KWL Prosthesis, Hip, Hemi-, Femoral, Metal LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer Orthopedic 2 KWL Prosthesis, Hip, Hemi-, Femoral, Metal Orthopedic 2 LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic 2 LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 04719872153733 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 04719872153733 04719872153733 4719872153733
GMDN Terms# Term, Definition table Term Definition Rotating hinged total knee prosthesis A sterile implantable artificial substitute for a knee joint typically designed to replace all the articulating surfaces of the joint [total knee arthroplasty (TKA)] because of major loss of stabilizing structures or bone around the knee, often from tumour resection, or to replace a dysfunctional knee prosthesis (revision); it is designed with a mechanism for joint rotation and its major components are connected for stability typically about a transverse axis posterior of the rotational axis. It typically includes femoral, tibial, and patellar components that articulate and with parts made of metal, ceramic, and/or polyethylene (PE); it may be implated with or without bone cement.
Regulatory Flags# DUNS number 656700556 Device count 1 Lot or batch true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 07611996142327 POLARSTEM Smith & Nephew, Inc. LWJ 2017-01-12 07611996142334 POLARSTEM Smith & Nephew, Inc. LWJ 2017-01-12 07611996142341 POLARSTEM Smith & Nephew, Inc. LWJ 2017-01-12 07611996142358 POLARSTEM Smith & Nephew, Inc. LWJ 2017-01-12 07611996142372 POLARSTEM Smith & Nephew, Inc. LWJ 2017-01-12 07611996142396 POLARSTEM Smith & Nephew, Inc. LWJ 2016-09-01 07611996074901 SL-PLUS Smith & Nephew, Inc. LWJ 2016-08-19 07611996074925 SL-PLUS Smith & Nephew, Inc. LWJ 2016-08-19 07611996074932 SL-PLUS Smith & Nephew, Inc. LWJ 2016-08-19 07611996074949 SL-PLUS Smith & Nephew, Inc. LWJ 2016-08-19 07611996074956 SL-PLUS Smith & Nephew, Inc. LWJ 2016-08-19 07611996074970 SL-PLUS Smith & Nephew, Inc. LWJ 2016-08-19 07611996074987 SL-PLUS Smith & Nephew, Inc. LWJ 2016-08-19 07611996074994 SL-PLUS Smith & Nephew, Inc. LWJ 2016-08-19 07611996075007 SL-PLUS Smith & Nephew, Inc. LWJ 2016-08-19 07611996075014 SL-PLUS Smith & Nephew, Inc. LWJ 2016-08-19 07611996075038 SL-PLUS Smith & Nephew, Inc. LWJ 2016-08-19 07611996095586 SLR-PLUS Smith & Nephew, Inc. LWJ 2016-08-19 07611996095593 SLR-PLUS Smith & Nephew, Inc. LWJ 2016-08-19 07611996095609 SLR-PLUS Smith & Nephew, Inc. LWJ 2016-08-19 07611996095623 SLR-PLUS Smith & Nephew, Inc. LWJ 2016-08-19 07611996095630 SLR-PLUS Smith & Nephew, Inc. LWJ 2016-08-19 07611996095647 SLR-PLUS Smith & Nephew, Inc. LWJ 2016-08-19 07611996095654 SLR-PLUS Smith & Nephew, Inc. LWJ 2016-08-19 07611996095661 SLR-PLUS Smith & Nephew, Inc. LWJ 2016-08-19 07611996095678 SLR-PLUS Smith & Nephew, Inc. LWJ 2016-08-19 07611996103427 POLARSTEM Smith & Nephew, Inc. LWJ 2016-07-25 07611996103434 POLARSTEM Smith & Nephew, Inc. LWJ 2016-07-25 07611996103441 POLARSTEM Smith & Nephew, Inc. LWJ 2016-07-25 07611996103458 POLARSTEM Smith & Nephew, Inc. LWJ 2016-07-25