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

    ROGOZINSKI SPINAL SYSTEM, ADD'L COMPONENTS

    K Number: K896106 · Decision Jun 25, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    321
    Registration Numbers
    321
    Same Product Code
    429
    Applicant Total
    71
    Review Days
    248

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    Basic Information

    Device Name
    ROGOZINSKI SPINAL SYSTEM, ADD'L COMPONENTS
    K Number
    K896106
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3050
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Richards Medical Co., Inc.
    Date Received
    October 20, 1989
    Decision Date
    June 25, 1990
    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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