FDA Hearing: Orthopaedic Devices Panel

CONCLUDED

Hearing
05/12/11 – 05/12/11

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Summary

Application for the premarket approval of Augment Bone Graft (Biomimetic).

On May 12, 2011, the committee will discuss, make recommendations, and vote on information related to the premarket approval application (PMA) for the Augment Bone Graft, sponsored by Biomimetic Therapeutics, Inc. The intended use of the device is as an alternative bone grafting substitute to autologous bone graft in applications to facilitate fusion in the ankle and foot without necessitating an additional invasive procedure to harvest the graft.

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