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

    RAYHACK OSTEOTOMY SYSTEM (MODIFICATION)

    K Number: K952766 · Decision Dec 13, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    519
    Registration Numbers
    519
    Same Product Code
    1313
    Applicant Total
    2
    Review Days
    196

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    Basic Information

    Device Name
    RAYHACK OSTEOTOMY SYSTEM (MODIFICATION)
    K Number
    K952766
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Creative Medical Designs, Inc.
    Date Received
    May 31, 1995
    Decision Date
    December 13, 1995
    Product Code
    HRS
    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
    HRS Plate, Fixation, Bone

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    Other Clearances by Creative Medical Designs, Inc.

    K Number Device Name
    K061955 RAYHACK LOW PROFILE LOCKING PLATE AND INSTRUMENTS