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

    MAKO MODULAR KNEE COMPARTMENTAL IMPLANT SYSTEM

    K Number: K082172 · Decision Nov 28, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    159
    Registration Numbers
    159
    Same Product Code
    113
    Applicant Total
    8
    Review Days
    119

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    Basic Information

    Device Name
    MAKO MODULAR KNEE COMPARTMENTAL IMPLANT SYSTEM
    K Number
    K082172
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3520
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mako Surgical Corporation
    Date Received
    August 1, 2008
    Decision Date
    November 28, 2008
    Product Code
    HSX
    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
    HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, 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
    K133039 RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM
    K121064 MAKOPLASTY TOTAL HIP APPLICATION, RIO STANDARD SYSTEM
    K112507 RESTORIS PARTIAL KNEE APPLICATION (PKA), RIO STANDARD SYSTEM
    K090763 RESTORIS MULTICOMPARTMENTAL KNEE (MCK) SYSTEM