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

    ACCIN BIPOLAR HEAD SYSTEM

    K Number: K080647 · Decision Jul 8, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    216
    Registration Numbers
    216
    Same Product Code
    98
    Applicant Total
    7
    Review Days
    123

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    Basic Information

    Device Name
    ACCIN BIPOLAR HEAD SYSTEM
    K Number
    K080647
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3390
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Accelerated Innovation, LLC
    Date Received
    March 7, 2008
    Decision Date
    July 8, 2008
    Product Code
    KWY
    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
    KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented

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    Other Clearances by Accelerated Innovation, LLC

    K Number Device Name
    K081127 ACCIN TOTAL KNEE SYSTEM
    K080539 ACCIN UNIPOLAR HEAD SYSTEM
    K073120 ACCIN PATELLOFEMORAL SYSTEM
    K073531 ACCIN PEDICLE SCREW SYSTEM
    K073530 ACCIN ANTERIOR CERVICAL PLATE SYSTEM
    K073068 ACCIN HIP SYSTEM