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

    ChoiceSpine Navigation System

    K Number: K203561 · Decision Jan 4, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    381
    Registration Numbers
    381
    Same Product Code
    430
    Applicant Total
    9
    Review Days
    28

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    Basic Information

    Device Name
    ChoiceSpine Navigation System
    K Number
    K203561
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.4560
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Choice Spine, LLC
    Date Received
    December 7, 2020
    Decision Date
    January 4, 2021
    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 Choice Spine, LLC

    K Number Device Name
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    K220953 ChoiceSpine TigerShark™ M, Modular Interbody System
    K220024 ChoiceSpine Navigation System
    K211449 Triton™ Sacroiliac Joint Fixation System
    K203311 ChoiceSpine Blackhawk Ti Cervical Spacer System
    K201643 ChoiceSpine Tiger Shark Cervical Spacer System
    K191621 ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer System Ascendant PC, ChoiceSpine Cervical Interbody Spacer System Ascendant, ChoiceSpine Cervical Spacer System Blackhawk, ChoiceSpine Intervertebral Fusion Device Octane Straight, ChoiceSpine Intervertebral Fusion Device Octane Straight PC, ChoiceSpine VEO Laterial Access & Interbody Fusion System
    K191367 Harrier-SA Lumbar Interbody System