Home GUDID 00840097509181 Kinos Axiom Total Ankle Replacement
Primary DI 00840097509181
Brand Kinos Axiom Total Ankle Replacement
Company Restor3d, Inc.
Model 1834-0020
Device description X-Stem Implant, Standard, Size 2, with Tidal Technology
Published 2024-01-18
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 HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00840097509181 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 00840097509181 00840097509181 840097509181 0840097509181
GMDN Terms# Term, Definition table Term Definition Coated ankle tibia prosthesis A sterile implantable device designed to replace the distal tibia (tibial component) as part of a primary ankle joint replacement or prosthesis revision. The device is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement.
Regulatory Flags# DUNS number 080819836 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 10381780237730 Cadence™ Ascension Orthopedics, Inc. HSN 2016-01-12 10381780237747 Cadence™ Ascension Orthopedics, Inc. HSN 2016-01-12 10381780237754 Cadence™ Ascension Orthopedics, Inc. HSN 2016-01-12 10381780237761 Cadence™ Ascension Orthopedics, Inc. HSN 2016-01-12 10381780237778 Cadence™ Ascension Orthopedics, Inc. HSN 2016-01-12 10381780237785 Cadence™ Ascension Orthopedics, Inc. HSN 2016-01-12 10381780237792 Cadence™ Ascension Orthopedics, Inc. HSN 2016-01-12 10381780237808 Cadence™ Ascension Orthopedics, Inc. HSN 2016-01-12 10381780237815 Cadence™ Ascension Orthopedics, Inc. HSN 2016-01-12 10381780237822 Cadence™ Ascension Orthopedics, Inc. HSN 2016-01-12 10381780237839 Cadence™ Ascension Orthopedics, Inc. HSN 2016-01-12 10381780237846 Cadence™ Ascension Orthopedics, Inc. HSN 2016-01-12 10381780237853 Cadence™ Ascension Orthopedics, Inc. HSN 2016-01-12 10381780237860 Cadence™ Ascension Orthopedics, Inc. HSN 2016-01-12 10381780237877 Cadence™ Ascension Orthopedics, Inc. HSN 2016-01-12 10381780237884 Cadence™ Ascension Orthopedics, Inc. HSN 2016-01-12 10381780237891 Cadence™ Ascension Orthopedics, Inc. HSN 2016-01-12 10381780237907 Cadence™ Ascension Orthopedics, Inc. HSN 2016-01-12 10381780237914 Cadence™ Ascension Orthopedics, Inc. HSN 2016-01-12 10381780237921 Cadence™ Ascension Orthopedics, Inc. HSN 2016-01-12 10381780237938 Cadence™ Ascension Orthopedics, Inc. HSN 2016-01-12 10381780237945 Cadence™ Ascension Orthopedics, Inc. HSN 2016-01-12 10381780237952 Cadence™ Ascension Orthopedics, Inc. HSN 2016-01-12 10381780237969 Cadence™ Ascension Orthopedics, Inc. HSN 2016-01-12 10381780237976 Cadence™ Ascension Orthopedics, Inc. HSN 2016-01-12 10381780237983 Cadence™ Ascension Orthopedics, Inc. HSN 2016-01-12 10381780237990 Cadence™ Ascension Orthopedics, Inc. HSN 2016-01-12 10381780238003 Cadence™ Ascension Orthopedics, Inc. HSN 2016-01-12 10381780238010 Cadence™ Ascension Orthopedics, Inc. HSN 2016-01-12 10381780238027 Cadence™ Ascension Orthopedics, Inc. HSN 2016-01-12