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

    MECRON MRC-HEADLESS FEMORAL COMPONENT

    K Number: K844486 · Decision Feb 19, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    149
    Registration Numbers
    149
    Same Product Code
    106
    Applicant Total
    14
    Review Days
    92

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    Basic Information

    Device Name
    MECRON MRC-HEADLESS FEMORAL COMPONENT
    K Number
    K844486
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3360
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Mecron Medical Products, Inc.
    Date Received
    November 19, 1984
    Decision Date
    February 19, 1985
    Product Code
    KWL
    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
    KWL Prosthesis, Hip, Hemi-, Femoral, Metal

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    Other Clearances by Mecron Medical Products, Inc.

    K Number Device Name
    K861138 MASH DERMATOME
    K854191 MECRON UNCEMENTED STRUCTURED STEM HIP
    K844775 EFFNER-EYE CAUTERY WITH BATTERY HANDLE
    K844774 EFFNER FIBER OPTIC CABLES FOR COLD LIGHT TRANSMISS
    K844488 MECRON CEMENTED STRUCTURED STEM HIP PROSTHESIS
    K844487 MECRON FEMORAL HEAD W/CONE AS UNIPOLAR OR BIPOLAR
    K844773 EFF-EFFNER BULBS
    K843449 AUTODYNAMIC COMPRESSION HIP SCREW-PLATE
    K843553 BONE PLATES
    K843554 BONE SCREWS
    Search all 14 clearances from Mecron Medical Products, Inc. →