510(k) K080108

CORTOSS BONE AUGMENTATION MATERIAL by Orthovita, Inc. — Product Code NDN

K080108 is an FDA 510(k) premarket notification submitted by Orthovita, Inc. for the device "CORTOSS BONE AUGMENTATION MATERIAL". The FDA issued a decision of Substantially Equivalent on June 5, 2009. The device falls under product code NDN (Cement, Bone, Vertebroplasty), a Class II device regulated under 21 CFR 888.3027. Orthovita, Inc. has at least 10 other 510(k) clearances on record.