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

    OSTEO EX-FI-RE

    K Number: K920149 · Decision Apr 9, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    68
    Registration Numbers
    68
    Same Product Code
    84
    Applicant Total
    9
    Review Days
    90

    Basic Information

    Device Name
    OSTEO EX-FI-RE
    K Number
    K920149
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    OSTEO AG
    Date Received
    January 10, 1992
    Decision Date
    April 9, 1992
    Product Code
    JEC
    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
    JEC Component, Traction, Invasive

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