510(k) K071927

MODIFICATION TO VERTEBROPLASTIC RADIOPAQUE BONE CEMENT by Depuy Spine, A Johnson & Johnson Company — Product Code NDN

K071927 is an FDA 510(k) premarket notification submitted by Depuy Spine, A Johnson & Johnson Company for the device "MODIFICATION TO VERTEBROPLASTIC RADIOPAQUE BONE CEMENT". The FDA issued a decision of Substantially Equivalent on November 21, 2007. The device falls under product code NDN (Cement, Bone, Vertebroplasty), a Class II device regulated under 21 CFR 888.3027. Depuy Spine, A Johnson & Johnson Company has at least 3 other 510(k) clearances on record.