Search Results

The Pedicle Screw System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities of thoracic, lumbar, and sacral spine: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; tumor; pseudoarthrosis; and failed previous fusion.

The Pedicle Screw System consists of longitudinal rods, polyaxial screws, and transverse connectors. It is manufactured from Ti-6Al-4V alloy conforming to ASTM F136.

This document describes the FDA 510(k) clearance for Black Box Medical LLC's Pedicle Screw System (K201751). It does not contain information about acceptance criteria or a study proving the device meets those criteria.

This submission is a declaration of substantial equivalence to a predicate device (Stowe Pedicle Screw System, K181554) and explicitly states: "Performance data is not included in this submission. The design changes being included for review are the same changes implemented and approved under K181554. No additional changes have been made for this submission that would require additional performance testing."

Therefore, I cannot provide the requested information regarding acceptance criteria and the study that proves the device meets them because this document indicates that such information was not part of this specific 510(k) submission (K201751). The clearance is based on substantial equivalence to a previously cleared device.

Ask a specific question about this device