510(k) K213287

StageOne Knee Cement Spacer Molds by Biomet, Inc. — Product Code MBB

K213287 is an FDA 510(k) premarket notification submitted by Biomet, Inc. for the device "StageOne Knee Cement Spacer Molds". The FDA issued a decision of Substantially Equivalent on September 2, 2022. The device falls under product code MBB (Bone Cement, Antibiotic), a Class II device regulated under 21 CFR 888.3027. Biomet, Inc. has at least 10 other 510(k) clearances on record.