510(k) K180700

KYPHON HV-R Bone Cement by Medtronic Sofamor Danek USA, Inc. — Product Code NDN

K180700 is an FDA 510(k) premarket notification submitted by Medtronic Sofamor Danek USA, Inc. for the device "KYPHON HV-R Bone Cement". The FDA issued a decision of Substantially Equivalent on May 18, 2018. The device falls under product code NDN (Cement, Bone, Vertebroplasty), a Class II device regulated under 21 CFR 888.3027. Medtronic Sofamor Danek USA, Inc. has 181 other 510(k) clearances on record.