Home GUDID M684E21020091 EVOLUTION
Primary DI M684E21020091
Brand EVOLUTION
Company Microport Orthopedics Inc.
Model E2102009
Catalog number E2102009
Device description EVOLUTION® KA TIBIA EM ANKLE CLAMP ASSEMBLY
Published 2019-12-23
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name HXD CLAMP
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HXD Clamp General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status M684E21020091 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Orthopaedic implant/instrument assembling device A non-sterile, noninvasive tool designed to support assembly of the component parts of an orthopaedic implant or surgical instrument during an orthopaedic surgical procedure, typically when component sizes are determined during the procedure [e.g., stem, neck, and head femoral components of a total hip arthroplasty (THA)]. It is available in one of a variety of forms (e.g., holder, clamp/press), however it is not a component of the final instrument/implant and is not a surgical screwdriver or wrench. 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 079118736 Device count 1 Premarket exempt true Lot or batch true Manufacturing date on label true Sterilization required before use true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published B8034503260 ORTHOMED ORTHO-MED, INC. HXD 2026-07-14 B8034503660 ORTHOMED ORTHO-MED, INC. HXD 2026-07-14 B8034503700 ORTHOMED ORTHO-MED, INC. HXD 2026-07-14 00840277133656 Innomed, Inc. INNOMED, INC. HXD 2026-05-29 ESAM3840131 STOMA® Storz am Mark GmbH HXD 2025-04-30 ESAM3841131 STOMA® Storz am Mark GmbH HXD 2025-04-30 14026704918680 PILLING TELEFLEX INCORPORATED HXD 2024-07-15 14026704918727 PILLING TELEFLEX INCORPORATED HXD 2024-07-15 10840199539571 Glover Bulldog KOROS U.S.A., INC. HXD 2024-02-02 10840199539588 Glover Bulldog KOROS U.S.A., INC. HXD 2024-02-02 10840199539595 Glover Bulldog KOROS U.S.A., INC. HXD 2024-02-02 10840199539601 Glover Bulldog KOROS U.S.A., INC. HXD 2024-02-02 10840199539618 Glover Bulldog KOROS U.S.A., INC. HXD 2024-02-02 10840199539625 Glover Bulldog KOROS U.S.A., INC. HXD 2024-02-02 10840199539632 Glover Bulldog KOROS U.S.A., INC. HXD 2024-02-02 10840199539649 Glover Bulldog KOROS U.S.A., INC. HXD 2024-02-02 10840199535894 Clamp KOROS U.S.A., INC. HXD 2024-01-31 10840199535948 Cardio Clamp KOROS U.S.A., INC. HXD 2024-01-31 10840199535955 Cardio Clamp KOROS U.S.A., INC. HXD 2024-01-31 10840199535979 Aortic Clamp KOROS U.S.A., INC. HXD 2024-01-31 10840199536013 Aortic Clamp KOROS U.S.A., INC. HXD 2024-01-31 10840199536020 Aortic Clamp KOROS U.S.A., INC. HXD 2024-01-31 10840199536037 Aortic Clamp KOROS U.S.A., INC. HXD 2024-01-31 10840199539410 Thoracic Clamp KOROS U.S.A., INC. HXD 2024-01-31 10840199539694 Dietrich Micro Coronary Bulldog KOROS U.S.A., INC. HXD 2024-01-31 10840199539724 DeBakey Bulldog Clamps KOROS U.S.A., INC. HXD 2024-01-31 10840199539731 DeBakey Bulldog Clamps KOROS U.S.A., INC. HXD 2024-01-31 10840199539748 DeBakey Bulldog Clamps KOROS U.S.A., INC. HXD 2024-01-31 10840199539755 DeBakey Bulldog Clamps KOROS U.S.A., INC. HXD 2024-01-31 10840199539762 DeBakey Bulldog Clamps KOROS U.S.A., INC. HXD 2024-01-31
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