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510(k) Data Aggregation

    K Number
    K183060
    Device Name
    CervAlign™ Anterior Cervical Plate System
    Manufacturer
    Pioneer Surgical Technology, Inc. (DBA RTI Surgical, Inc.)
    Date Cleared
    2019-01-17

    (76 days)

    Product Code
    KWQ,KWO
    Regulation Number
    888.3060
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K130427,K083663
    Why did this record match?
    Device Name :

    CervAlign™ Anterior Cervical Plate System

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The CervAlign Anterior Cervical Plate System is intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudarthrosis, and failed previous fusion.

    Device Description

    The CervAlign Anterior Cervical Plate System is designed to promote cervical fusion by providing temporary resistance to flexion, extension, lateral bending, and axial rotation with strength and stiffness in the cervical spine (C2-C7). The system includes implants of various sizes of screws and plates to accommodate varying patient anatomies. The plates have integrated cover-style locking mechanisms that actuate to cover each screw. Implants are manufactured from titanium alloy, Ti-6Al-4V ELI instrumentation necessary to facilitate the insertion and removal. The implants and instruments are provided non-sterile and must be sterilized before use. Sterilization cases and trays are provided to facilitate proper sterilization and storage.

    AI/ML Overview

    The provided text describes a medical device, the CervAlign™ Anterior Cervical Plate System, and its regulatory clearance. However, it does not contain the specific information requested regarding AI/CADe device acceptance criteria or related studies. The document is a 510(k) summary for a physical orthopedic implant, not an AI-powered diagnostic or assistive device. Therefore, I cannot provide the details about acceptance criteria, clinical study specifics, ground truth establishment, or sample sizes in the context of AI/CADe devices based on this input.

    The document discusses non-clinical mechanical testing and MR safety evaluations to demonstrate substantial equivalence to predicate devices, which is typical for physical implants.

    If you have a document related to an AI/CADe device, please provide that, and I will be happy to extract the requested information.

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