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

    ORTHOPAEDIC STAPLES

    K Number: K890962 · Decision May 15, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    245
    Registration Numbers
    245
    Same Product Code
    230
    Applicant Total
    2
    Review Days
    77

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    Basic Information

    Device Name
    ORTHOPAEDIC STAPLES
    K Number
    K890962
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Ortho Spectrum, Inc.
    Date Received
    February 27, 1989
    Decision Date
    May 15, 1989
    Product Code
    JDR
    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
    JDR Staple, Fixation, Bone

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    Other Clearances by Ortho Spectrum, Inc.

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