510(k) K252443

SpaceFix Shoulder Spacer by G21, S.R.L. — Product Code MBB

K252443 is an FDA 510(k) premarket notification submitted by G21, S.R.L. for the device "SpaceFix Shoulder Spacer". The FDA issued a decision of Substantially Equivalent on September 15, 2025. The device falls under product code MBB (Bone Cement, Antibiotic), a Class II device regulated under 21 CFR 888.3027. G21, S.R.L. has at least 10 other 510(k) clearances on record.