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

    STERNAL BAND

    K Number: K930015 · Decision May 19, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    155
    Registration Numbers
    155
    Same Product Code
    128
    Applicant Total
    2
    Review Days
    135

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    Basic Information

    Device Name
    STERNAL BAND
    K Number
    K930015
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3010
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Stony Brook Surgical Innovations, Inc.
    Date Received
    January 4, 1993
    Decision Date
    May 19, 1993
    Product Code
    JDQ
    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
    JDQ Cerclage, Fixation

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    Other Clearances by Stony Brook Surgical Innovations, Inc.

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    K013059 STONY BROOK SURGICAL INNOVAIONS STERNA-WIRE (STERNAL SUTURES)