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

    RELIANCE VBS SYSTEM

    K Number: K063637 · Decision Sep 27, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    222
    Registration Numbers
    222
    Same Product Code
    276
    Applicant Total
    24
    Review Days
    294

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    Basic Information

    Device Name
    RELIANCE VBS SYSTEM
    K Number
    K063637
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3060
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Reliance Medical Systems, LLC
    Date Received
    December 7, 2006
    Decision Date
    September 27, 2007
    Product Code
    MQP
    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
    MQP Spinal Vertebral Body Replacement Device

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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
    K183049 Reliance Lumbar IBF System
    K173283 Reliance Lumbar IBF System
    K173102 Reliance Cervical IBF System
    K172489 Reliance Cervical IBF System
    K162066 Reliance Spinal Screw System
    K160463 Reliance Lumbar IBF System
    K152131 Reliance Spinal Screw System
    K142269 Reliance Cervical IBF System
    Search all 24 clearances from Reliance Medical Systems, LLC →