Home GUDID 00840097509204 Kinos Axiom Total Ankle Replacement
Primary DI 00840097509204
Brand Kinos Axiom Total Ankle Replacement
Company Restor3d, Inc.
Model 1834-0030
Device description X-Stem Implant, Standard, Size 3, 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 00840097509204 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 00840097509204 00840097509204 840097509204 0840097509204
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 00840097534237 Kinos Aeros Total Ankle Replacement Restor3d, Inc. HSN 2026-07-31 00840097534244 Kinos Aeros Total Ankle Replacement Restor3d, Inc. HSN 2026-07-31 00840097534251 Kinos Aeros Total Ankle Replacement Restor3d, Inc. HSN 2026-07-31 00840097534268 Kinos Aeros Total Ankle Replacement Restor3d, Inc. HSN 2026-07-31 00840097534275 Kinos Aeros Total Ankle Replacement Restor3d, Inc. HSN 2026-07-31 00840097534282 Kinos Aeros Total Ankle Replacement Restor3d, Inc. HSN 2026-07-31 00889797111089 PROPHECY INCOMPASS WRIGHT MEDICAL TECHNOLOGY, INC. HSN 2026-06-23 00889797111096 PROPHECY INCOMPASS WRIGHT MEDICAL TECHNOLOGY, INC. HSN 2026-06-23 00889797111102 PROPHECY INCOMPASS WRIGHT MEDICAL TECHNOLOGY, INC. HSN 2026-06-23 00889797111119 PROPHECY INCOMPASS WRIGHT MEDICAL TECHNOLOGY, INC. HSN 2026-06-23 00889797111126 PROPHECY INCOMPASS WRIGHT MEDICAL TECHNOLOGY, INC. HSN 2026-06-23 00889797114820 PROPHECY INCOMPASS WRIGHT MEDICAL TECHNOLOGY, INC. HSN 2026-06-23 00889797114837 PROPHECY INCOMPASS WRIGHT MEDICAL TECHNOLOGY, INC. HSN 2026-06-23 B095322305 Hintermann Series H2 Dt Medtech, LLC HSN 2018-03-20 B095322306 Hintermann Series H2 Dt Medtech, LLC HSN 2018-03-20 B095322307 Hintermann Series H2 Dt Medtech, LLC HSN 2018-03-20 B095322315 Hintermann Series H2 Dt Medtech, LLC HSN 2018-03-20 B095322316 Hintermann Series H2 Dt Medtech, LLC HSN 2018-03-20 B095322317 Hintermann Series H2 Dt Medtech, LLC HSN 2018-03-20 B095322325 Hintermann Series H2 Dt Medtech, LLC HSN 2018-03-20 B095322326 Hintermann Series H2 Dt Medtech, LLC HSN 2018-03-20 B095322327 Hintermann Series H2 Dt Medtech, LLC HSN 2018-03-20 B095322329 Hintermann Series H2 Dt Medtech, LLC HSN 2018-03-20 B095322129 Hintermann Series H2 Dt Medtech, LLC HSN 2018-03-19 B095322215 Hintermann Series H2 Dt Medtech, LLC HSN 2018-03-19 B095322216 Hintermann Series H2 Dt Medtech, LLC HSN 2018-03-19 B095322217 Hintermann Series H2 Dt Medtech, LLC HSN 2018-03-19 B095322219 Hintermann Series H2 Dt Medtech, LLC HSN 2018-03-19 B095322226 Hintermann Series H2 Dt Medtech, LLC HSN 2018-03-19 10381780237730 Cadence™ Ascension Orthopedics, Inc. HSN 2016-01-12