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

    ALPHA ORTHOPAEDICS AT2 SYSTEM

    K Number: K082956 · Decision Dec 18, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    2
    Review Days
    76

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    Basic Information

    Device Name
    ALPHA ORTHOPAEDICS AT2 SYSTEM
    K Number
    K082956
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alpha Orthopaedics
    Date Received
    October 3, 2008
    Decision Date
    December 18, 2008
    Product Code
    GEI
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    Y

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GEI Electrosurgical, Cutting & Coagulation & Accessories

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    Other Clearances by Alpha Orthopaedics

    K Number Device Name
    K094041 ALPHA ORTHOPAEDICS AT3 SYSTEM