Acute Instabilities Thoracic, Lumbar and Sacral Spine Clinical Trial
Official title:
A Prospective Randomized Postmarket Clinical Study of the TRANSITION Stabilization System
This postmarket surveillance study is being conducted to evaluate the TRANSITION Stabilization System as an adjunct to fusion in the treatment of acute or chronic instabilities or deformities of the thoracic, lumbar and sacral spine. The study will involve up to 360 subjects at no more than 20 sites, to be treated with the TRANSITION Stabilization System. The data from this postmarket surveillance study will be provided to FDA in accordance with the 522 order.
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