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

    EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM

    K Number: K050766 · Decision May 26, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    387
    Registration Numbers
    387
    Same Product Code
    75
    Applicant Total
    10
    Review Days
    62

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    Basic Information

    Device Name
    EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM
    K Number
    K050766
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4820
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Zimmer Trabecular
    Date Received
    March 25, 2005
    Decision Date
    May 26, 2005
    Product Code
    HWE
    Advisory Committee
    General, Plastic Surgery
    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
    HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

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