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

    BONE SCREW

    K Number: K943804 · Decision Dec 8, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    659
    Registration Numbers
    659
    Same Product Code
    1058
    Applicant Total
    5
    Review Days
    126

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    Basic Information

    Device Name
    BONE SCREW
    K Number
    K943804
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Cohort Medical Products Group, Inc.
    Date Received
    August 4, 1994
    Decision Date
    December 8, 1994
    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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    Other Clearances by Cohort Medical Products Group, Inc.

    K Number Device Name
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