510(k) K150408

V-STEADY, V-FAST by G21, S.R.L. — Product Code LOD

K150408 is an FDA 510(k) premarket notification submitted by G21, S.R.L. for the device "V-STEADY, V-FAST". The FDA issued a decision of Substantially Equivalent on December 14, 2015. The device falls under product code LOD (Bone Cement), a Class II device regulated under 21 CFR 888.3027. G21, S.R.L. has at least 10 other 510(k) clearances on record.