Search Results

The Integrated Spine System is indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) at the LS-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous hone graff and having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion mass.

Use of a rod and ileo-sacral screw fixation system, T1-S1, the lumbar screws and rods will assist in arthrodesis or fusion of the lumbar spine. The indications for use are:

1. Spondylolisthesis
2. Spinal Fractures
3. Spinal Stenosis
4. Deformities (Idiopathic Scoliosis, Adult Kyphosis, Lordosis)
5. Pseudarthrosis of previous fusion
6. Instability caused by Trauma o1 Tumors
7. Revision of previously failed fusion surgery
8. Degenerative Disk Discasc
9. Stabilization after Osteotomy

Not Found

The provided text is a 510(k) premarket notification letter from the FDA to Ortho Development Corporation for their Integrated Spine System (ISS). It details the device's classification, regulatory information, and indications for use.

However, the document does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria for performance metrics. It's a regulatory clearance document, not a performance study report.

Therefore, I cannot provide the requested information based solely on the provided text.

To answer your questions, I would need a different type of document, such as:

• A clinical study report
• A summary of safety and effectiveness data (often submitted with 510(k)s but not included in this FDA clearance letter)
• A detailed performance testing report

Without such a document, any answers would be speculative and not based on the provided input.

Ask a specific question about this device