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The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1 to S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.

The FOCUS Pedicle Screw System is a spinal system used as an adjunct to fusion, to provide immobilization and stabilization of spinal segments in the non-cervical posterior spine (T1 to S1) of skeletally mature patients. The system consists in pedicle screws implanted into the bones, and capturing spinal rods. The system is stabilized by cross connectors. The device is implanted via a posterior approach.

This document is a 510(k) premarket notification for the "FOCUS Pedicle Screw System" and does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device.

The provided text pertains to a traditional medical device (a pedicle screw system for spinal fixation) and its substantial equivalence determination by the FDA. The evaluation of this device is based on non-clinical mechanical testing and comparison to predicate devices, not on AI/ML performance metrics.

Therefore, the requested information cannot be extracted from the provided input, as it describes a different type of device and regulatory review process.

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