(18 days)
Each BONE GRAFT WASHER is intended to stabilize the bone graft at one level (T1-S I ) as an aid to spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials (e.g., commercially pure titanium or titanium alloy).
The BONE GRAFT WASHER is a temporary implant used to prevent bone graft extrusion. The washer is also intended to provide temporary stabilization and augment development of a solid spinal fusion. The BONE GRAFT WASHER consists of a variety of sizes of washers used with a screw. The purpose of this submission is to make include modified washers and an additional screw to the system.
The provided text describes a 510(k) submission for the BONE GRAFT WASHER II, focusing on its substantial equivalence to itself (meaning an updated version of an already approved device). However, it does not contain information about acceptance criteria, performance studies, or details relevant to artificial intelligence (AI) or machine learning (ML) models.
Therefore, I cannot populate the requested table and answer the study-related questions based on the provided input. The document is primarily a regulatory approval letter for a physical medical device, not a software or AI-driven diagnostic/therapeutic tool.
If the request refers to a different type of device or study not detailed in the provided text, please provide relevant information.
§ 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.