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The device system consisting of screws, washers, spacers, utilizing the anterolateral/anterior surgical approach is intended for the following uses: (a) anterolateral screw fixation to the non-cervical spine, (b) anterior screw fixation to the cervical spine. The anterolateral/anterior system is intended for use in the following indications: (a) Degenerative disc disease of the lumbar thoracic and cervical spine relating to discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies. (b) Spondylolisthesis (c) Trauma (d) Spinal Stenosis (e) Scoliosis (f) Kyphosis (g) Tumor (h) Pseudoarthrosis (i) Revision of previous surgery (j) Neoplastia. The device system consisting of hooks, screws, washers, spacers, when utilized as a non-pedicle posterior system has the following intended use: (a) hook and sacral/iliac screw fixation to the non-cervical spines. The non-pedicle posterior devices may be used for the following indications: Degenerative disc disease of the lumbar thoracic and cervical spine relating to discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies. (b) Spondylolisthesis (c) Trauma (d) Spinal Stenosis (e) Scoliosis (f) Kyphosis (g) Tumor (h) Pseudoarthrosis (i) Revision of previous surgery (j) Neoplastia. The device system consisting of hooks, spacers, sacral/iliac screws and pedicle screws is intended for patients: (a) Having a severe spondylolisthesis (grades 3 and 4) at the L5-S1 joint (b) Who are receiving fusions using autogenous bone graft only (c) Who are having the device fixed or attached to the lumbar and sacral spine (d) Who are having the device removed after the development of a solid fusion mass. The levels of pedicle screws fixation will be L3-S1.

A spinal system consisting of screws, hooks, washers, spacers, rods, and rod plates/screws. The pedicle screws are available in four diameters from 5mm to 8mm, and vary in length from 30mm to 55mm. The spinal rods have a diameter of 4.75mm and vary in length from 50mm to 500mm. The anterior washers offer use with 5mm, 6mm, and 7mm screws. The Conical spacers are available in three heights from 7mm to 12mm, increasing in 2.5mm increments. The lumbo-sacral rod/plate and screw incorporates lumbo-sacral rod/plates in three lengths from 80mm to 120mm, and bone screws with a 7mm diameter and lengths of 30mm to 45mm, increasing in 5mm increments. There are five laminar hooks and one pedicle hook within the range. The system is intended for use anterolateral/anterior, non-pedicle posterior and posterior pedicle. The distal tips of the pedicle screws are fluted to a point beyond the first thread, thus creating a self-tapping screw configuration. The pedicle screw lengths are offered in 5mm increments from 30mm to 55mm. The screw diameters are offered in 1mm increments from 5mm to 8mm diameters. The spinal rods have a diameter of 4.75mm and vary in length from 50mm to 500mm. The locking mechanism between the rod and screw, as well as the rod and hook, features a three point clamping configuration in order to significantly reduce the risk of rod pistoning and migration. The devices are manufactured from titanium alloy or stainless steel. All components are completely interchangeable with each other, but only components manufactured from the same material may be used in combination.

The provided text is a 510(k) summary for the Corin Spinal System, a medical device. It details the device's description, indications for use, and the FDA's decision regarding its substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria, device performance metrics, or study results (clinical or analytical) that would "prove the device meets the acceptance criteria."

510(k) summaries primarily focus on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed performance studies with acceptance criteria as one would find for a new, novel device requiring a PMA or specific performance standards.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The requested information points (1) through (9) are not present in this 510(k) summary.

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