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

    RESTORIS POROUS PARTIAL KNEE SYSTEM

    K Number: K150410 · Decision Mar 20, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    124
    Registration Numbers
    124
    Same Product Code
    90
    Applicant Total
    8
    Review Days
    30

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    Basic Information

    Device Name
    RESTORIS POROUS PARTIAL KNEE SYSTEM
    K Number
    K150410
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3530
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mako Surgical Corporation
    Date Received
    February 18, 2015
    Decision Date
    March 20, 2015
    Product Code
    HRY
    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
    HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer

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