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

    Altus Spine Pedicle Screw System

    K Number: K200322 · Decision Jun 2, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    407
    Registration Numbers
    407
    Same Product Code
    900
    Applicant Total
    17
    Review Days
    113

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    Basic Information

    Device Name
    Altus Spine Pedicle Screw System
    K Number
    K200322
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Altus Partners, LLC
    Date Received
    February 10, 2020
    Decision Date
    June 2, 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 Altus Partners, LLC

    K Number Device Name
    K243419 Altus Spine Navigation System
    K211027 Altus Spine Pedicle Screw System
    K211837 Altus Spine Interbody Standalone Fusion System
    K210887 Altus Spine Sochi OCT Spinal System
    K200922 Altus Spine HA Pedicle Screw System
    K183084 Fuji Cervical Plate System
    K182406 Altus Spine Interbody Fusion System
    K181339 Altus Spine Pedicle Screw System
    K181281 Altus Spine Pedicle Screw System
    K170553 Altus Spine Interbody Fusion System
    Search all 17 clearances from Altus Partners, LLC →