(224 days)
The Samson Corpectomy System is a vertebral body replacement system indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T1 to L5). The Samson Corpectomy System is intended for use with supplemental fixation and is to be used with autograft and/or allograft.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA to Verticor, LTD regarding the Samson Corpectomy System. This document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
Specifically, the document discusses:
- The FDA's review of the 510(k) submission.
- A determination of "substantial equivalence" to a predicate device.
- Regulatory requirements for the device (e.g., registration, labeling, manufacturing practices).
- Contact information for various FDA offices.
- The indications for use for the Samson Corpectomy System.
There is no mention of specific performance metrics, acceptance criteria, study designs, sample sizes, ground truth establishment, or expert involvement as would be required to answer the questions posed.
Therefore, I cannot provide the requested information based on the given input.
§ 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.