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

    WHITESIDE BIOMECHANICS CANCELLOUS BONE SCREW

    K Number: K961157 · Decision May 17, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    659
    Registration Numbers
    659
    Same Product Code
    1058
    Applicant Total
    13
    Review Days
    56

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    Basic Information

    Device Name
    WHITESIDE BIOMECHANICS CANCELLOUS BONE SCREW
    K Number
    K961157
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Whiteside Biomechanics, Inc.
    Date Received
    March 22, 1996
    Decision Date
    May 17, 1996
    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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