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

    Curiteva Navigation System

    K Number: K223200 · Decision Jan 6, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    381
    Registration Numbers
    381
    Same Product Code
    430
    Applicant Total
    11
    Review Days
    85

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    Basic Information

    Device Name
    Curiteva Navigation System
    K Number
    K223200
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4560
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Curiteva, Inc.
    Date Received
    October 13, 2022
    Decision Date
    January 6, 2023
    Product Code
    OLO
    Advisory Committee
    Neurology
    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
    OLO Orthopedic Stereotaxic Instrument

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    Other Clearances by Curiteva, Inc.

    K Number Device Name
    K252205 Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody System; Curiteva Porous PEEK Laminoplasty System; Curiteva Porous PEEK Standalone ALIF System
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    K243137 Curiteva Porous PEEK Laminoplasty System
    K233360 Curiteva Thoracolumbar Plate System
    K233744 Curiteva Porous PEEK Lumbar Interbody Fusion System
    K231232 Curiteva Laminoplasty System
    K213030 Curiteva Porous PEEK Cervical Interbody Fusion System
    K210402 Curiteva Sacroiliac Joint Fusion System
    K191810 Curiteva Pedicle Screw System
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