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

    RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM

    K Number: K133039 · Decision Dec 10, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    69
    Registration Numbers
    69
    Same Product Code
    11
    Applicant Total
    8
    Review Days
    75

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    Basic Information

    Device Name
    RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM
    K Number
    K133039
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3560
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mako Surgical Corporation
    Date Received
    September 26, 2013
    Decision Date
    December 10, 2013
    Product Code
    NPJ
    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
    NPJ Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

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    Other Clearances by Mako Surgical Corporation

    K Number Device Name
    K142530 Partial Knee Application (PKA)
    K150410 RESTORIS POROUS PARTIAL KNEE SYSTEM
    K141989 MAKOPLASTY TOTAL HIP ALLPICATION, RIO STANDARD SYSTEM
    K121064 MAKOPLASTY TOTAL HIP APPLICATION, RIO STANDARD SYSTEM
    K112507 RESTORIS PARTIAL KNEE APPLICATION (PKA), RIO STANDARD SYSTEM
    K090763 RESTORIS MULTICOMPARTMENTAL KNEE (MCK) SYSTEM
    K082172 MAKO MODULAR KNEE COMPARTMENTAL IMPLANT SYSTEM