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

    Cadence Total Ankle System

    K Number: K201507 · Decision Jun 29, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    65
    Applicant Total
    7
    Review Days
    24

    Basic Information

    Device Name
    Cadence Total Ankle System
    K Number
    K201507
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3110
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Integra Lifesciences Corporation
    Date Received
    June 5, 2020
    Decision Date
    June 29, 2020
    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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