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

    POLARIS SPINAL SYSTEM

    K Number: K100220 · Decision May 17, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    407
    Registration Numbers
    407
    Same Product Code
    900
    Applicant Total
    95
    Review Days
    111

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    Basic Information

    Device Name
    POLARIS SPINAL SYSTEM
    K Number
    K100220
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ebi, L.P.
    Date Received
    January 26, 2010
    Decision Date
    May 17, 2010
    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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    Other Clearances by Ebi, L.P.

    K Number Device Name
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    K092574 ESL SPINAL SYSTEM
    K093057 BIOMET VISION FOOTRING SYSTEM
    K092336 C-THRU SPINAL SYSTEM
    K091381 IBEX SPINAL SYSTEM
    K090203 5.5 HELICAL FLANGE SPINAL SYSTEM, POLARIS COMPONENTS
    K090523 POLARIS SPINAL SYSTEM
    K082406 EXPANDABLE PEEK-OPTIMA IMPLANT
    K082187 BIOMET ANTERIOR LUMBAR PLATE
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