BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    restor3d Kinos Axiom Total Ankle System

    K Number: K240591 · Decision Apr 29, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    92
    Same Product Code
    67
    Applicant Total
    6
    Review Days
    59

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    Basic Information

    Device Name
    restor3d Kinos Axiom Total Ankle System
    K Number
    K240591
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3110
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Restor3D, Inc.
    Date Received
    March 1, 2024
    Decision Date
    April 29, 2024
    Product Code
    HSN
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer

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