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

    5.5 POLARIS SPINAL SYSTEM

    K Number: K091067 · Decision Jul 14, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    407
    Registration Numbers
    407
    Same Product Code
    900
    Applicant Total
    19
    Review Days
    91

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    Basic Information

    Device Name
    5.5 POLARIS SPINAL SYSTEM
    K Number
    K091067
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biomet Spine
    Date Received
    April 14, 2009
    Decision Date
    July 14, 2009
    Product Code
    NKB
    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
    NKB Thoracolumbosacral Pedicle Screw System

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    K141791 BIOMET FUSION SYSTEM
    K121130 POLARIS SPINAL SYSTEM-BALLISTA SPINAL RODS
    K112014 ZYSTON STRAIGHT SPACER SYSTEM
    K103393 POLARIS SPINAL SYSTEM
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