510(k) K131135

BIOMET STAGE ONE DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY HEMI-SHOULDER PROSTHESIS by Biomet Manufacturing Corp — Product Code MBB

K131135 is an FDA 510(k) premarket notification submitted by Biomet Manufacturing Corp for the device "BIOMET STAGE ONE DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY HEMI-SHOULDER PROSTHESIS". The FDA issued a decision of Substantially Equivalent on January 22, 2014. The device falls under product code MBB (Bone Cement, Antibiotic), a Class II device regulated under 21 CFR 888.3027. Biomet Manufacturing Corp has at least 10 other 510(k) clearances on record.