(78 days)
The CORRIDOR™ Fixation System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints, with or without bone graft, at single or multiple levels, from C2 to S1 for 3.5mm and 4.0mm screws and from L1 to S1 for 4.5mm screws. For transfacet fixation, the screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. For translaminar facet fixation, the screws are inserted posteriorly through the lateral aspect of the spinous process, through the lamina, through the superior side of the facet, across the facet joint, and into the pedicle.
The CORRIDOR™ Fixation System is indicated for treatment of any or all of the following: pseudoarthrosis and failed previous fusions which are symptomatic or which may cause secondary instability or deformity; spondylolisthesis; spondylolysis; degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies; degeneration of the spine; instability and trauma including spinal fractures and/or dislocations.
The CORRIDOR™ Fixation System consists of screws designed to compact juxtaposed facet articular processes to enhance spinal fusion. The screws are available partially threaded or fully threaded, cannulated or non-cannulated, and in various diameters and lengths to accommodate patient anatomy. The CORRIDOR™ Fixation System screws are fabricated from medical grade titanium alloy as specified in ASTM F136 and F1295. Due to the risk of galvanic corrosion, titanium alloy implants should not be used in the same construct as stainless steel implants.
This document is a 510(k) summary for the Globus Medical Inc. CORRIDOR™ Fixation System, a spinal implant. It describes the device, its intended use, and states that it is substantially equivalent to legally marketed predicate devices based on similarities in indications, design, materials, and performance.
The provided text does not contain any information regarding the acceptance criteria for a device, a study proving the device meets those criteria, or any details about a study's methodology, sample sizes, expert involvement, ground truth, or statistical analysis.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from the given input. The document is solely a regulatory submission summary for substantial equivalence, not a scientific study report.
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