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

    IN-FAST BONE SCREW SYSTEM

    K Number: K011910 · Decision Jul 13, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    659
    Registration Numbers
    659
    Same Product Code
    1058
    Applicant Total
    72
    Review Days
    24

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    Basic Information

    Device Name
    IN-FAST BONE SCREW SYSTEM
    K Number
    K011910
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    American Medical Systems, Inc.
    Date Received
    June 19, 2001
    Decision Date
    July 13, 2001
    Product Code
    HWC
    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
    HWC Screw, Fixation, Bone

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