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Approvals and Clearances - US Surgical

This article was originally published in Clinica

Executive Summary

The FDA has approved United States Surgical's Ray Threaded Fusion Cage (TFC). The cage is a hollow, threaded cylinder which replaces degenerated vertebrae discs and provides spinal support during bone in-growth. Surgical Dynamics, a subsidiary of US Surgical based in Norwalk, Connecticut, is marketing the product. The company says that in clinical trials the cage successfully fused the spines of 92% of 236 patients. The US market for spinal fusion devices is estimated at $300 million annually and the international market is potentially of equal value.

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