Search Results

The Atrax Anterior Cervical Plating System is intended for anterior fixation of the cervical spine. The system is indicated for use in temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with the following: Degenerative Disc Disease (as identified by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), Spondylolisthesis, Trauma (i.e., fracture or dislocation), Spinal tumors, Deformity (e.g., kyphosis, lordosis, scoliosis), Pseudarthrosis, and/or Failed previous fusion.

The Atrax Anterior Cervical Plating System consists of screws and plates offered in various sizes so that adaptations can be made to take into account pathology and individual patient anatomy. The Atrax System allows for anterior fixation of between one and four intervertebral segments between C2 and C7.

The Atrax Anterior Cervical Plating System implants are manufactured from Titanium alloy in accordance with ASTM F136 and will be provided sterile (gamma irradiation). All implants are intended for single use only and should not be reused under any circumstances.

The system includes a series of manual surgical instruments intended to assist the insertion and placement of the implants. The instrumentation will be packaged and sold clean but non-sterilization cycle is recommended in the Atrax System draft Instructions for Use.

The provided text is a 510(k) summary for the Atrax™ Anterior Cervical Plating System and does not contain information about an AI/ML powered device or software.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies related to an AI/ML device. The document describes a medical device (spinal intervertebral body fixation orthosis) and its substantial equivalence to predicate devices based on material biocompatibility and mechanical performance tests. It does not mention any AI or machine learning components.

Ask a specific question about this device