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

    ORTHOMED ORTHOPAEDIC FIXATION STAPLES

    K Number: K861137 · Decision Apr 17, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    245
    Registration Numbers
    245
    Same Product Code
    230
    Applicant Total
    2
    Review Days
    22

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    Basic Information

    Device Name
    ORTHOMED ORTHOPAEDIC FIXATION STAPLES
    K Number
    K861137
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Biomedical Exports, Inc.
    Date Received
    March 26, 1986
    Decision Date
    April 17, 1986
    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 Biomedical Exports, Inc.

    K Number Device Name
    K860291 TUBING CONNECTORS