Search Results

The NuVasive SmartPlate Gradient Plus System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disc disease defined as neek pain of discogenic origin with the degeneration of the disc contirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudarthrosis or failed previous fusion.

WARNING: The NuVasive SmartPlate Gradient Plus System is not intended for screw attachment or fixation to the posterior clements (pedicles) of the cervical, thoracic or lumbar spine.

The Nu Vasive SmartPlate Gradient Plus System consists of a variety of plates, screws, and screw-retaining covers designed to provide stabilization as an adjunct to cervical fusion.

The provided text describes a 510(k) premarket notification for a medical device called the NuVasive SmartPlate Gradient Plus System. It does not contain information about acceptance criteria, device performance, a study proving acceptance criteria, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

The document primarily focuses on establishing substantial equivalence to a predicate device based on identical indications for use and principles of operation, supported by mechanical testing. Clinical tests are explicitly marked as "Not Applicable," meaning no human clinical study was performed.

Therefore, I cannot provide the requested information from the given text. The text does not describe a study that would include such details.

Ask a specific question about this device