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510(k) Data Aggregation

    K Number
    K213871
    Device Name
    Ennovate Cervical Spinal and Occiput System
    Manufacturer
    Aesculap Implant Systems, LLC.
    Date Cleared
    2022-07-01

    (200 days)

    Product Code
    NKG
    Regulation Number
    888.3075
    Why did this record match?
    Applicant Name (Manufacturer) :

    Aesculap Implant Systems, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Aesculap Ennovate Cervical Spinal and Occiput System is intended to provide immobilization of spinal segments as an adjunct to following acute and chronic instabilities of the craniocervical junction, the cervical spine (Cl to C7) and the thoracic spine (Tl-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radior myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Aesculap Ennovate Cervical Spinal and Occiput System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. In order to achieve additional levels of fixation, the Aesculap Ennovate Lumbar System may be connected to the Aesculap Ennovate Cervical Spinal and Occiput System using connectors and rods.
    Device Description
    The Aesculap ENNOVATE Cervical Spinal and Occiput System is implant systems used to facilitate the biological process of spinal fusion. This system is intended to promote fusion of the cervical and thoracic spine (C1-T3) and occipito-cervico-thoracic junction (occiput-T3). The Aesculap ENNOVATE Cervical Spinal and Occiput System consist of various plates, screws, rods, hooks, and connectors.
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