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1. The device system consisting screws, washers, spacers, utilizing the anterolateral surgical approach is intended for the following uses:
   (a) anterolateral scrow 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

2. The device system consisting of hooks, screws, washers, spacers, when utilized as a non-pedicte posterior system has the following intended use:
   hook and sacral/iliac screw fixation to the non-cervical spine

The non-pedicle posterior devices may be used for the following indications:
(a) Degenerative disc discase of the lumbar thoracic and cervical spinc relating to discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies.
(b) Spondy lulisthesis
(c) Trauma
(d) Spinal Sicnosis
(e) Scoliosis
(f) Kyphosis.
(g) Tumor
(h) Pseudoanthrosis
(i) Revision of previous surgery
(j) Neoplastia

3. The device system consisions of hooks, spacers, sucral/iliae screws and pedicale screws is intended for patients:
   (a) Having a severe spondyloslisthesis (grades 3 and 4) at the I.S-SI joint
   (b) Who ure receiving fusions using autogenous bone graft only
   (c) Who are having the device lixed or auached to the lumbar and sacral spine
   (d) Who are having the device removed after the development of a solid fusion mass

The levels of pedicte screws fixation will be 1.3-S1.

The device system consisting screws, washers, spacers, utilizing the anterolateral surgical approach.
The device system consisting of hooks, screws, washers, spacers, when utilized as a non-pedicte posterior system.
The device system consisions of hooks, spacers, sucral/iliae screws and pedicale screws.

This document is a 510(k) clearance letter from the FDA for a medical device called the "Trifix Pedicle Spinal Screw Assembly" for use in the Corin Spinal System. It does not contain information about acceptance criteria or a study proving device performance against such criteria.

The letter explicitly states that the FDA reviewed the 510(k) notification and determined the device is "substantially equivalent" to legally marketed predicate devices. This means the device was cleared based on its similarity to existing devices, not necessarily on a new clinical study demonstrating specific performance metrics against pre-defined acceptance criteria.

Therefore, I cannot provide the requested information from this document.

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