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

    ChoiceSpine Tiger Shark Cervical Spacer System

    K Number: K201643 · Decision Dec 22, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    339
    Registration Numbers
    339
    Same Product Code
    348
    Applicant Total
    9
    Review Days
    188

    Basic Information

    Device Name
    ChoiceSpine Tiger Shark Cervical Spacer System
    K Number
    K201643
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3080
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Choice Spine, LLC
    Date Received
    June 17, 2020
    Decision Date
    December 22, 2020
    Product Code
    ODP
    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
    ODP Intervertebral Fusion Device With Bone Graft, Cervical

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    Other Clearances by Choice Spine, LLC

    K Number Device Name
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    K211449 Triton™ Sacroiliac Joint Fixation System
    K203311 ChoiceSpine Blackhawk Ti Cervical Spacer System
    K203561 ChoiceSpine Navigation 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