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

    INQU

    K Number: K071428 · Decision Sep 17, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    229
    Registration Numbers
    229
    Same Product Code
    491
    Applicant Total
    4
    Review Days
    117

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    Basic Information

    Device Name
    INQU
    K Number
    K071428
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3045
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Isto Technologies, Inc.
    Date Received
    May 23, 2007
    Decision Date
    September 17, 2007
    Product Code
    MQV
    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
    MQV Filler, Bone Void, Calcium Compound

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    Other Clearances by Isto Technologies, Inc.

    K Number Device Name
    K111838 INQU PASTE MIX
    K103799 INQU PASTE MIX PLUS
    K063359 INQU