Home GUDID 10381780237754 Cadence™
Primary DI 10381780237754
Brand Cadence™
Company Ascension Orthopedics, Inc.
Model 10209148
Catalog number 10209148
Device description The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidly fixed to the Tibial Tray intra-operatively. In conjunction with the Talar Dome and Tibial Tray, the system is intended for both primary surgery and revision surgery applications which are designed to treat ankle arthritis through replacement of the ankle joint with a prosthesis, thereby reducing pain, restoring alignment, and allowing for movement at the replaced joint. These components are available in a variety of sizes and design configurations.
Published 2016-01-12
Public version status Update
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 10381780237754 Primary GS1 0 M268102091481 Secondary HIBCC 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10381780237754 10381780237754
GMDN Terms# Term, Definition table Term Definition Fixed-bearing total ankle prosthesis A sterile implantable artificial substitute for an ankle joint designed to replace the main articulating surfaces of the damaged (e.g., fractured) and/or degenerative (e.g., arthritic) joint. It includes tibial and talar components typically with parts made of metal and polyethylene (PE); the PE bearing that articulates the two components is attached or moulded to one of the components. Fixation devices (e.g., screws) for implantation may be included and implantation may be performed with or without bone cement.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Store in a clean, dry environment. Protect from sunlight and extreme temperatures.
Regulatory Flags# DUNS number 942377524 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 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 10381780238034 Cadence™ Ascension Orthopedics, Inc. HSN 2016-01-12
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