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

    ACCIN UNIPOLAR HEAD SYSTEM

    K Number: K080539 · Decision Jun 2, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    227
    Registration Numbers
    227
    Same Product Code
    562
    Applicant Total
    7
    Review Days
    96

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    Basic Information

    Device Name
    ACCIN UNIPOLAR HEAD SYSTEM
    K Number
    K080539
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3350
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Accelerated Innovation, LLC
    Date Received
    February 27, 2008
    Decision Date
    June 2, 2008
    Product Code
    JDI
    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
    JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

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    Other Clearances by Accelerated Innovation, LLC

    K Number Device Name
    K081127 ACCIN TOTAL KNEE SYSTEM
    K080647 ACCIN BIPOLAR HEAD SYSTEM
    K073120 ACCIN PATELLOFEMORAL SYSTEM
    K073531 ACCIN PEDICLE SCREW SYSTEM
    K073530 ACCIN ANTERIOR CERVICAL PLATE SYSTEM
    K073068 ACCIN HIP SYSTEM