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

    BLACKSTONE ASCENT MULTIAXIAL SCREWS

    K Number: K073420 · Decision Feb 14, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    321
    Registration Numbers
    321
    Same Product Code
    429
    Applicant Total
    45
    Review Days
    71

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    Basic Information

    Device Name
    BLACKSTONE ASCENT MULTIAXIAL SCREWS
    K Number
    K073420
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3050
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Blackstone Medical, Inc.
    Date Received
    December 5, 2007
    Decision Date
    February 14, 2008
    Product Code
    KWP
    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
    KWP Appliance, Fixation, Spinal Interlaminal

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