510(k) K193061

G3 40 Radiopaque Bone Cement by G21, S.R.L. — Product Code LOD

K193061 is an FDA 510(k) premarket notification submitted by G21, S.R.L. for the device "G3 40 Radiopaque Bone Cement". The FDA issued a decision of Substantially Equivalent on March 19, 2020. 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.