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Cellent Spinal Systems are intended for posterior pedicle screw fixation of the non-cervical posterior spine in sketally mature patients. It provides stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities:

• (1) Trauma (i.e. fracture or dislocation),
• (2) curvatures (scoliosis, kyphosis, and/or lordosis),
• (3) spinal tumor,
• (4) failed previous fusion
• (5) pseudarthrosis,
• (6) spinal stenosis.
  Cellent Spinal Systems are not intended for pedicle screw fixation above T8.

Cellent Spinal System is a combination of pedicle screws, pedicle hooks, rods, set screws, connectors, and cross links, which can fix the vertebral body through pedicle or lamina. It is made of Titanium Alloy (Ti-6AL-41V ELI), which meet ASTM F136-13, Standard Specification for Wrought Titanium-6 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surgical implants.

I am unable to provide a response based on the provided input. The document describes a medical device called "Cellent Spinal Systems," which is a thoracolumbosacral pedicle screw system. The document focuses on its substantial equivalence to predicate devices, non-clinical data (performance testing), and the conclusion that animal or clinical studies were not required for this submission.

There is no information regarding an AI/algorithm-based device, acceptance criteria related to software performance, or a study that evaluates its performance characteristics against predefined acceptance criteria for an AI or software-based medical device. Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, or MRMC studies.

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