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When used as a pedicle screw fixation system (MNH) The Contour™ Spinal System is PC PC indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) at the L5-S1 indicated for the treating to ture patients receiving fusion by autogenous bone graft having ventooral joint in skelonymbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion mass.

Use of a hook, rod, and ileo-sacral screw fixation system (KWP) T1-S1, the Lumbar Hook Sacral Screw Construct of the Contour " Spinal System, will assist in arthrodesis or fusion of the thoracic, lumbar and lumbosacral spine. The indications for use are:

• Spondylolisthesis; .
• Fracture:
• Spinal Stenosis;
• Deformities (scoliosis, kyphosis, lordosis); .
• Pseudarthrosis ●
• Tumor ●
• Revision of previously failed fusion surgery .

The hooks are to be used for fixation to include the first thoracic vertebra down to the sacrum. The pedicle screws are used for sacral fixation only.

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The provided text is a 510(k) clearance letter from the FDA for the Contour Spinal System, dated October 14, 1999. It states that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain information about acceptance criteria, device performance, studies conducted, sample sizes, ground truth establishment, or expert qualifications. The clearance letter primarily confirms that the device can be marketed based on its substantial equivalence to existing devices.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input. The document is a regulatory clearance and not a study report.

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