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

    MAKOPLASTY TOTAL HIP APPLICATION, RIO STANDARD SYSTEM

    K Number: K121064 · Decision Jun 6, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    381
    Registration Numbers
    381
    Same Product Code
    430
    Applicant Total
    8
    Review Days
    61

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    Basic Information

    Device Name
    MAKOPLASTY TOTAL HIP APPLICATION, RIO STANDARD SYSTEM
    K Number
    K121064
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.4560
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mako Surgical Corporation
    Date Received
    April 6, 2012
    Decision Date
    June 6, 2012
    Product Code
    OLO
    Advisory Committee
    Neurology
    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
    OLO Orthopedic Stereotaxic Instrument

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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
    K112507 RESTORIS PARTIAL KNEE APPLICATION (PKA), RIO STANDARD SYSTEM
    K090763 RESTORIS MULTICOMPARTMENTAL KNEE (MCK) SYSTEM
    K082172 MAKO MODULAR KNEE COMPARTMENTAL IMPLANT SYSTEM