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

    Reliance Lumbar IBF System

    K Number: K160463 · Decision May 20, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    422
    Registration Numbers
    422
    Same Product Code
    869
    Applicant Total
    23
    Review Days
    91

    Basic Information

    Device Name
    Reliance Lumbar IBF System
    K Number
    K160463
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3080
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Reliance Medical Systems, LLC
    Date Received
    February 19, 2016
    Decision Date
    May 20, 2016
    Product Code
    MAX
    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
    MAX Intervertebral Fusion Device With Bone Graft, Lumbar

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    Other Clearances by Reliance Medical Systems, LLC

    K Number Device Name
    K202266 Reliance Cervical IBF System
    K210874 Reliance Spinal Screw System
    K173283 Reliance Lumbar IBF System
    K173102 Reliance Cervical IBF System
    K172489 Reliance Cervical IBF System
    K162066 Reliance Spinal Screw System
    K152131 Reliance Spinal Screw System
    K142269 Reliance Cervical IBF System
    K142867 Reliance Posterior Cervical-Thoracic System
    K142217 Reliance Interspinous Plate System
    Search all 23 clearances from Reliance Medical Systems, LLC →