510(k) K122175

MENDEC SPINE HV, MENDEC SPINE HV SYSTEM by Tecres S.P.A. — Product Code NDN

K122175 is an FDA 510(k) premarket notification submitted by Tecres S.P.A. for the device "MENDEC SPINE HV, MENDEC SPINE HV SYSTEM". The FDA issued a decision of Substantially Equivalent on March 28, 2013. 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.