Search Results

The Precision Surgery Limited Variable and Fixed Cervical Plate System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disc disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudarthrosis or failed previous fusion.

The Precision Surgery Limited Variable and Fixed Cervical Plate System includes plates and screw components. There are three types of plates available, two variable and one fixed. Primary and rescue screws are available.

The provided text is a 510(k) summary for the "Precision Surgery Limited Variable and Fixed Cervical Plate System." This document is a premarket notification for a medical device and describes its intended use, materials, and substantial equivalence to existing devices. It does not contain information about acceptance criteria, study designs, sample sizes, expert ground truth, or performance metrics typically found in clinical or performance studies.

Therefore, I cannot provide the requested information from the given text.

The 510(k) summary primarily focuses on demonstrating substantial equivalence to predicate devices, meaning it argues that the new device is as safe and effective as a legally marketed device. This typically involves comparing design, materials, and intended use, rather than conducting new performance studies against specific acceptance criteria.

Ask a specific question about this device