BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    REESE OSTEOTOMY GUIDE SYS

    K Number: K841470 · Decision May 23, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    2
    Applicant Total
    3
    Review Days
    44

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    Basic Information

    Device Name
    REESE OSTEOTOMY GUIDE SYS
    K Number
    K841470
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    888.4600
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Osteotomy Guide Co.
    Date Received
    April 9, 1984
    Decision Date
    May 23, 1984
    Product Code
    HTH
    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
    HTH Protractor

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