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

    ACCIN PEDICLE SCREW SYSTEM

    K Number: K073531 · Decision Feb 4, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    326
    Registration Numbers
    326
    Same Product Code
    308
    Applicant Total
    7
    Review Days
    49

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    Basic Information

    Device Name
    ACCIN PEDICLE SCREW SYSTEM
    K Number
    K073531
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Accelerated Innovation, LLC
    Date Received
    December 17, 2007
    Decision Date
    February 4, 2008
    Product Code
    MNH
    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
    MNH Orthosis, Spondylolisthesis Spinal Fixation

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    Other Clearances by Accelerated Innovation, LLC

    K Number Device Name
    K081127 ACCIN TOTAL KNEE SYSTEM
    K080647 ACCIN BIPOLAR HEAD SYSTEM
    K080539 ACCIN UNIPOLAR HEAD SYSTEM
    K073120 ACCIN PATELLOFEMORAL SYSTEM
    K073530 ACCIN ANTERIOR CERVICAL PLATE SYSTEM
    K073068 ACCIN HIP SYSTEM