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The CODA Anterior Cervical Plate System is intended for anterior fixation of the cervical spine (C2-C7) as an adjunct to fusion is skeletally mature patients. Specific indications include: 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, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

The CODA™ Anterior Cervical Plate (ACP) System is intended for anterior fixation of the cervical spine (C2-C7) as an adjunct to fusion in skeletally mature patients. The system consists of non-sterile plates and screws that are manufactured from titanium alloy (Ti-6Al-4V ELI). The plates have an integrated active locking mechanism, are offered in various lengths, and accommodate constrained and variable screws. The system includes nonsterile, reusable instruments and sterile, single use instruments designed to facilitate proper implantation of the plate and screws.

This document is a 510(k) summary for the CODA™ Anterior Cervical Plate System. It describes the device, its intended use, and provides a conclusion of substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria, device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.

Therefore, I cannot provide the requested information based on the text provided. The document primarily focuses on regulatory approval based on demonstrating equivalence to an already marketed device, rather than detailed performance study results.

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