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FSU Total Spinal Segment Replacement (Prod 10363)
About FSU Total Spinal Segment Replacement (Prod 10363)
FSU Total Spinal Segment Replacement is designed to provide an alternative to fusion by reestablishing mobility in an affected segment of the lumbar spine. The device is composed of an interbody disc component (Core) and posterior dynamic resistance component (Dampener) and is designed as a system to restore the motion and natural kinematics of the affected spine segment. The Food and Drug Administration (FDA) has granted a conditional approval to begin the initial phase of the Investigational Device Exemption (IDE) for a feasibility study of its FSU device. This is the first approved clinical study for a Total Spine Arthroplasty system in the U.S (4/22/2010).
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As an important component of the service function of OrthopaedicLIST.com, some products continue to be listed that are no longer manufactured and may not be available. We will identify them as such when possible. This allows users to find special instruments and/or components for removal, modification, and/or revision of those products.
OrthopaedicLIST.com is a list of products and services. Every effort is made to keep this listing as accurate and current as possible. Companies and individuals are encouraged to notify us of errors and omissions. We will respond to such messages of correction in a timely fashion, as our workload permits.
We are non-judgmental of products listed. We are not in the business of evaluating products. We have not evaluated these products. We make no representations as to the quality, effectiveness, suitability or appropriateness of any of the products listed.
As an important component of the service function of OrthopaedicLIST.com, some products continue to be listed that are no longer manufactured and may not be available. We will identify them as such when possible. This allows users to find special instruments and/or components for removal, modification, and/or revision of those products.