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510(k) Data Aggregation

    K Number
    K132122
    Device Name
    KESTREL POSTERIOR CERVICAL SPINE SYSTEM
    Manufacturer
    OMNI SURGICAL LLC DBA SPINE360
    Date Cleared
    2014-01-22

    (196 days)

    Product Code
    KWP
    Regulation Number
    888.3050
    Why did this record match?
    Applicant Name (Manufacturer) :

    OMNI SURGICAL LLC DBA SPINE360

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Kestrel Posterior Cervical Fixation System is intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput - T3). The system is intended for posterior, cervical, non-pedicle fixation, or for posterior, noncervical pedicle fixation for the following indications: - Degenerative disc disease (DDD) defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies - Spondylolisthesis - Trauma (i.e fracture or dislocation) - Spinal stenosis, curvatures (i.e. scoliosis, kyphosis, and /or lordosis) - Tumor - Pseudoarthrosis - Failed previous fusion Occipital bone screws are limited to occipital fixation only. Pedicle bone screws are limited to placement in the upper thoracic spine (TI, T3) when anchoring the OCT construct only. Pedicle screws are not intended to be placed in the cervical spine. Hooks and wires (not pedicle screws) are used to achieve cervical fusion for the occipital/cervical loop
    Device Description
    The proposed SPINE360 Kestrel system consists of screws, locking caps, rods, cross links, hooks, and instruments.
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