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

    LineSider™ Spinal System

    K Number: K203367 · Decision Dec 3, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    407
    Registration Numbers
    407
    Same Product Code
    900
    Applicant Total
    11
    Review Days
    17

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    Basic Information

    Device Name
    LineSider™ Spinal System
    K Number
    K203367
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Integrity Implants, Inc.
    Date Received
    November 16, 2020
    Decision Date
    December 3, 2020
    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 Integrity Implants, Inc.

    K Number Device Name
    K231098 LineSider® Spinal System
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    K203038 Toro-L Interbody Fusion System
    K202198 FlareHawk Interbody Fusion System
    K201367 FlareHawk TiHawk9 Interbody Fusion System
    K190360 LineSider™ Spinal System
    K183184 FlareHawk Interbody Fusion System
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