(64 days)
The NuVasive Lateral Plate System is indicated for use as an adjunct to fusion via a 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 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 lock nut. Implant components can be rigidly locked to suit the individual pathology and anatomical conditions of the patient.
This NuVasive Lateral Plate System submission does not include any information about acceptance criteria or a study to prove the device meets acceptance criteria.
The provided documents consist of a 510(k) summary and the FDA's clearance letter for the NuVasive Lateral Plate System. These documents primarily cover:
- Device identification and classification: Trade name, common name, classification, and product code.
- Predicate devices: Stating that the device is substantially equivalent to previously cleared devices.
- Device description: Overview of components.
- Intended Use: The medical conditions and spinal regions for which the device is indicated.
- Substantial Equivalence: A statement that data was provided to demonstrate substantial equivalence based on indications, design, material, and function.
- Summary of Non-Clinical Tests: Mention of mechanical testing.
- Summary of Clinical Tests: Explicitly states "(Not Applicable)".
- FDA Clearance Letter: Confirms the 510(k) clearance based on substantial equivalence.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving device performance because it is not present in the provided text.
The document states "Summary of Clinical Tests (Not Applicable)", which indicates that no clinical study was performed or required for this 510(k) submission. The FDA clearance was based on substantial equivalence to predicate devices, supported by non-clinical (mechanical) testing.
§ 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.