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1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) Spinal stenosis, 3) Spondylolisthesis, 4) Spinal deformities, 5) Fractures, 6) Pseudarthrosis,7) Tumor resection, 8) Failed previous Fusion. When used as Fixation system the multiaxial screw components are also indicated for skeletally mature patients: a. Having severe spondylolisthesis (grade 3 or 4) of the L5-S1 vertebral joint, b. Who are receiving fusion using authogeneous bone graft only, c. Who are having the device fixed or attached to the lumbar or sacral spine (L.3 and below), d. Who are having the device removed after the development of solid fusion mass.

The Vertelink KOBRA™ Spinal Fixation System is designed to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the acute and pationic instabilities or deformities of the lumbar spine, spinal tumor and failed previous fusions. It can be used in either percutaneous or open surgery procedures. The system is composed of titanium pedicle screws and rods that are implanted in posterior manner either during an open surgical procedure or percutaneously using minimally invasive techniques.

The provided text is a 510(k) premarket notification for a medical device called the "Vertelink KOBRA™ Fixation System". This type of document is used to demonstrate that a new medical device is substantially equivalent to a legally marketed predicate device, rather than proving it meets specific acceptance criteria through a study.

Therefore, the document does not contain the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or MRMC comparative effectiveness studies. These are typically associated with performance studies for certain types of devices, especially those involving AI or diagnostic interpretations, which is not the case for this spinal fixation system.

The core of this submission is to show substantial equivalence to an existing device (CD HORIZON® Spinal System, K030932) based on similar technological characteristics and indications for use, rather than to present a de novo clinical performance study against pre-defined acceptance criteria.

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