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Inadequate data sinks Sofamor Danek bid to get its spinal fusion cage approved

This article was originally published in Clinica

Executive Summary

Sofamor Danek, the latest company to seek FDA approval for a spinal fusion cage, was rejected by an advisory committee on December 11. After tabling a motion to recommend approval of Sofamor's Novus LC with conditions, the FDA's orthopaedics and rehabilitation devices advisory committee voted 6-2 against.






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