510(k) K240856

Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds by Osartis GmbH — Product Code MBB

K240856 is an FDA 510(k) premarket notification submitted by Osartis GmbH for the device "Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds". The FDA issued a decision of Substantially Equivalent on November 20, 2024. The device falls under product code MBB (Bone Cement, Antibiotic), a Class II device regulated under 21 CFR 888.3027. Osartis GmbH has at least 5 other 510(k) clearances on record.