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

    ARTHROSCOPE W/CANNULATED OBTUR/DRILL BITS & WRENCH

    K Number: K861268 · Decision May 16, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    386
    Registration Numbers
    386
    Same Product Code
    680
    Applicant Total
    95
    Review Days
    46

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    Basic Information

    Device Name
    ARTHROSCOPE W/CANNULATED OBTUR/DRILL BITS & WRENCH
    K Number
    K861268
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.1100
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Orthopedic Systems, Inc.
    Date Received
    March 31, 1986
    Decision Date
    May 16, 1986
    Product Code
    HRX
    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
    HRX Arthroscope

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