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

    LAGUNA SIZE 8 PEDICLE SCREW SYSTEM

    K Number: K091995 · Decision Aug 7, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    407
    Registration Numbers
    407
    Same Product Code
    900
    Applicant Total
    7
    Review Days
    36

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    Basic Information

    Device Name
    LAGUNA SIZE 8 PEDICLE SCREW SYSTEM
    K Number
    K091995
    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
    July 2, 2009
    Decision Date
    August 7, 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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    Other Clearances by Allez Spine, LLC

    K Number Device Name
    K091219 DEL MAR MONOAXIAL PEDICLE SCREW SYSTEM
    K083826 LAGUNA POLYAXIAL PEDICLE SCREW SYSTEM
    K072678 LAGUNA SIZE 8 PEDICLE SCREW
    K070460 ALLEZ SPINE CROSS CONNECTORS
    K051275 LAGUNA MONOAXIAL PEDICLE SCREW SYSTEM
    K050060 LAGUNA PEDICLE SCREW SYSTEM