Home GUDID 00885556795064 LEGION
Primary DI 00885556795064
Brand LEGION
Company Smith & Nephew, Inc.
Model E0017148-5
Catalog number E0017148-5
Device description TIBIAL BASEPLATE TRIAL SZ 5 LT W/ BOSS
Published 2020-10-07
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name HRY PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00885556795064 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00885556795064 00885556795064 885556795064 0885556795064
GMDN Terms# Term, Definition table Term Definition Knee tibia prosthesis trial A copy of a final tibia prosthesis designed to be used during unicompartmental knee replacement surgery or total knee arthroplasty (TKA) to determine the correct alignment, size, and fit of the final prosthesis. It is one of a set, or a set, of graduated sizes, and may be used in conjunction with a knee femur trial prosthesis and a patella trial prosthesis. It is typically made of metal or polymer material and includes tibial base plate trials, tibial spacer trials, tibial insert trials, tibial stem trials, tibial wedge/augment trials, and guide pin trials. This is a reusable device intended to be sterilized prior to use.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 045483575 Device count 1 Premarket exempt true Lot or batch true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00885556833933 Salto Talaris Total Ankle Prosthesis MJU952T MJU952T 2022-12-22 00885556833940 Salto Talaris Total Ankle Prosthesis MJU953T MJU953T 2022-12-22 00885556833957 Salto Talaris Total Ankle Prosthesis MJV219T MJV219T 2022-12-22 00885556833964 Salto Talaris Total Ankle Prosthesis MJV220T MJV220T 2022-12-22 00885556833971 Salto Talaris Total Ankle Prosthesis MJV221T MJV221T 2022-12-22 00885556833988 Salto Talaris Total Ankle Prosthesis MJV229T MJV229T 2022-12-22 00885556834237 Silicone Toe System CGT-205T CGT-205T 2022-12-22 00885556834251 Silicone Toe System CGT-305T CGT-305T 2022-12-22 00885556834299 Silicone Toe System CGT-505T CGT-505T 2022-12-22 00885556835029 Ti6 Internal Fixation System DS1007 DS1007 2022-12-22 00885556835203 Surgical Instruments FS-1006 FS-1006 2022-12-22 00885556836187 Ti6 Internal Fixation System TH3018 TH3018 2022-12-22 00885556837856 Total Foot System 2 2204250 2204250 2022-12-22 00885556838785 Total Foot System 2 2823027 2823027 2022-12-21 00885556841631 XT Revision Ankle Replacement System MJU984T MJU984T 2022-12-21 00885556841778 XT Revision Ankle Replacement System MJV222T MJV222T 2022-12-21 00885556841785 XT Revision Ankle Replacement System MJV223T MJV223T 2022-12-21 00885556854921 Freedom Wrist Arthroplasty System 348047 348047 2022-12-22 00885556856680 Surgical Instruments EXT-200-00 EXT-200-00 2022-12-22 00885556860168 Titan Modular Shoulder System 2.5 DRL-0923-047-001 DRL-0923-047-001 2022-12-22
Other Devices Sharing Product Codes# 
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