NEW YORK (Thomson Financial) - Orthovita Inc. Tuesday said it submitted a
510(k) filing to the Food and Drug Administration for use of its Cortoss bone
augmentation material in vertebral augmentation.
If the FDA clears Cortoss, Orthovita would be permitted to market and sell
the material in the U.S. Cortoss already is certified for sale in the European
Union.
Orthovita said it was basing its filing on the results of three clinical
investigations conducted in the U.S. under the FDA's investigational device
exemptions.
Shares of Orthovita, a Malvern, Pa.-based health-care company, closed Monday
at $3.28.
Ryan Vlastelica
rv/jw
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