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Video of a Liver Resection that uses Vitagel®
Vitagel® is an FDA approved surgical hemostat used to control bleeding and facilitate healing while utilizing the patient's own biology. Vitagel not only has the ability to work over small surgical areas, but large ones, as well, as with this patient, who underwent a Liver Resection.
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Pre-Clinical Testing of Spinal Implants: Safety Versus Substantial Equivalence
Historically, the differences between the performance data threshold necessary to earn IDE approval versus the threshold to get 510(k) clearance has been very simple because most devices were clearly either class II or class III, where their design could clearly distinguish their intended use. However, a new trend is changing the landscape.
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Equation Spinal System
The Equation™ System incorporates a semi-rigid design that balances strength with flexibility. The Equation™ System is a reduced-volume and top-tightening spinal instrumentation system. This system provides a means of fixation that mimics the load distribution of natural human anatomy (i.e., semi-rigid system designed to share, not bear, the load). Stabilizes the thoracic, lumbar, and sacral spine, especially as an adjunct to interbody construct placement. Assists with the reduction of spondylolisthesis and spinal deformities, such as kyphosis and hyperlordosis. Provides supplemental fixation in cases involving vertebral instabilities, including fractures and dislocation..
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