Home GUDID 00885556795101 LEGION
Primary DI 00885556795101
Brand LEGION
Company Smith & Nephew, Inc.
Model E0017148-9
Catalog number E0017148-9
Device description TIBIAL BASEPLATE TRIAL SZ 1 RT 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 00885556795101 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 00885556795101 00885556795101 885556795101 0885556795101
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 00885556830543 PyroCarbon Modular Radial Head TRL-310-01 TRL-310-01 2026-09-24 00885556830550 PyroCarbon Modular Radial Head TRL-310-02 TRL-310-02 2026-09-24 00885556830567 PyroCarbon Modular Radial Head TRL-310-03 TRL-310-03 2026-09-24 00885556830574 PyroCarbon Modular Radial Head TRL-310-04 TRL-310-04 2026-09-24 00885556839690 Total Foot System 2 CSA-800-06 CSA-800-06 2026-09-24 00885556839706 Total Foot System 2 CSA-800-07 CSA-800-07 2026-09-24 00885556854778 Cadence Total Ankle System CSA-1020-0014 CSA-1020-0014 2026-09-24 00885556859636 Titan Modular Shoulder System CSA092009 CSA092009 2026-09-24 00885556859643 Titan Modular Shoulder System CSA092010 CSA092010 2026-09-24 00885556859650 Titan Modular Shoulder System CSA092011 CSA092011 2026-09-24 00885556859698 Titan Modular Shoulder System CSA-0920-15 CSA-0920-15 2026-09-24 00885556859704 Titan Modular Shoulder System CSA-0920-16 CSA-0920-16 2026-09-24 00885556859711 Titan Modular Shoulder System CSA-0920-17 CSA-0920-17 2026-09-24 00885556859728 Titan Modular Shoulder System CSA-0920-18 CSA-0920-18 2026-09-24 00885556859735 Titan Modular Shoulder System CSA-0920-19 CSA-0920-19 2026-09-24 00885556859742 Titan Modular Shoulder System CSA-0920-20 CSA-0920-20 2026-09-24 00885556859759 Titan Modular Shoulder System CSA-0920-21 CSA-0920-21 2026-09-24 00885556859766 Titan Modular Shoulder System CSA-0920-22 CSA-0920-22 2026-09-24 00885556859773 Titan Modular Shoulder System CSA-0920-23 CSA-0920-23 2026-09-24 00885556859780 Titan Modular Shoulder System CSA-0920-24 CSA-0920-24 2026-09-24
Other Devices Sharing Product Codes# 
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