510(k) K220131

KYPHON VuE Bone Cement by Tecres S.P.A. — Product Code NDN

K220131 is an FDA 510(k) premarket notification submitted by Tecres S.P.A. for the device "KYPHON VuE Bone Cement". The FDA issued a decision of Substantially Equivalent on April 18, 2022. The device falls under product code NDN (Cement, Bone, Vertebroplasty), a Class II device regulated under 21 CFR 888.3027. Tecres S.P.A. has at least 10 other 510(k) clearances on record.