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

    SPINAL FIXATION SYSTEM

    K Number: K092536 · Decision Oct 30, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    407
    Registration Numbers
    407
    Same Product Code
    900
    Applicant Total
    23
    Review Days
    72

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    Basic Information

    Device Name
    SPINAL FIXATION SYSTEM
    K Number
    K092536
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Lanx, Inc.
    Date Received
    August 19, 2009
    Decision Date
    October 30, 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 Lanx, Inc.

    K Number Device Name
    K131547 LANX FUSION SYSTEM
    K131156 LANX SPINAL FIXATION SYSTEM
    K123767 LANX FUSION SYSTEM- SA
    K121316 LANX SPINAL FIZATION SYSTEM
    K122145 LANX SPINAL FIXATION SYSTEM
    K121940 LANX SPINAL FIXATION SYSTEM
    K113434 LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS)
    K112388 LANX CERVICAL SA
    K103091 LANX SPINAL FIXATION SYSTEM
    K103237 LANX SPINAL SYSTEM
    Search all 23 clearances from Lanx, Inc. →