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

    CKS POROUS COATED FEMORAL COMPONENT

    K Number: K933935 · Decision Oct 11, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    124
    Registration Numbers
    124
    Same Product Code
    90
    Applicant Total
    31
    Review Days
    426

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    Basic Information

    Device Name
    CKS POROUS COATED FEMORAL COMPONENT
    K Number
    K933935
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3530
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Techmedica, Inc.
    Date Received
    August 11, 1993
    Decision Date
    October 11, 1994
    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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