(64 days)
The NuVasive Lateral Plate System is indicated for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery.
The NuVasive Lateral Plate System consists of a variety of plates, screws, bolts, and locking nuts. Implant components can be rigidly locked to suit the individual pathology and anatomical conditions of the patient.
The provided text describes a 510(k) premarket notification for the NuVasive Lateral Plate System, which is a medical device. This document does not contain information about software with acceptance criteria, reported device performance, sample sizes for test or training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.
The document pertains to a physical medical device (spinal implants) and focuses on demonstrating substantial equivalence to previously cleared devices through mechanical testing and comparison of indications for use, design, material, and function. There is no mention of an AI/ML device or software in this submission.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.