510(k) K160071

StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis by Biomet, Inc. — Product Code MBB

K160071 is an FDA 510(k) premarket notification submitted by Biomet, Inc. for the device "StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis". The FDA issued a decision of Substantially Equivalent on June 16, 2016. 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.