510(k) K112905

COMPRESS(R) SEGMENTAL HUMERAL REPLACEMENT SYSTEM by Biomet Orthopedics, LLC — Product Code MBF

K112905 is an FDA 510(k) premarket notification submitted by Biomet Orthopedics, LLC for the device "COMPRESS(R) SEGMENTAL HUMERAL REPLACEMENT SYSTEM". The FDA issued a decision of Substantially Equivalent on May 24, 2012. The device falls under product code MBF (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented), a Class II device regulated under 21 CFR 888.3670. Biomet Orthopedics, LLC has at least 10 other 510(k) clearances on record.