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

    LAGUNA SIZE 8 PEDICLE SCREW

    K Number: K072678 · Decision Jul 2, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    407
    Registration Numbers
    407
    Same Product Code
    900
    Applicant Total
    7
    Review Days
    285

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    Basic Information

    Device Name
    LAGUNA SIZE 8 PEDICLE SCREW
    K Number
    K072678
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Allez Spine, LLC
    Date Received
    September 21, 2007
    Decision Date
    July 2, 2008
    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 Allez Spine, LLC

    K Number Device Name
    K091995 LAGUNA SIZE 8 PEDICLE SCREW SYSTEM
    K091219 DEL MAR MONOAXIAL PEDICLE SCREW SYSTEM
    K083826 LAGUNA POLYAXIAL PEDICLE SCREW SYSTEM
    K070460 ALLEZ SPINE CROSS CONNECTORS
    K051275 LAGUNA MONOAXIAL PEDICLE SCREW SYSTEM
    K050060 LAGUNA PEDICLE SCREW SYSTEM