510(k) K100479

PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE by Arthrocare Corp. — Product Code NDN

K100479 is an FDA 510(k) premarket notification submitted by Arthrocare Corp. for the device "PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE". The FDA issued a decision of Substantially Equivalent on September 21, 2010. The device falls under product code NDN (Cement, Bone, Vertebroplasty), a Class II device regulated under 21 CFR 888.3027. Arthrocare Corp. has at least 10 other 510(k) clearances on record.