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

    Integra Total Ankle Replacement System

    K Number: K151459 · Decision Aug 31, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    92
    Same Product Code
    67
    Applicant Total
    7
    Review Days
    91

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    Basic Information

    Device Name
    Integra Total Ankle Replacement System
    K Number
    K151459
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3110
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ascension Orthopedics
    Date Received
    June 1, 2015
    Decision Date
    August 31, 2015
    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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