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

    S.T.E.P. UNI-KNEE

    K Number: K940389 · Decision Jan 19, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    124
    Registration Numbers
    124
    Same Product Code
    90
    Applicant Total
    1
    Review Days
    358

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    Basic Information

    Device Name
    S.T.E.P. UNI-KNEE
    K Number
    K940389
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3530
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    S.T.E.P. Orthopaedics, Inc.
    Date Received
    January 26, 1994
    Decision Date
    January 19, 1995
    Product Code
    HRY
    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
    HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer

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