510(k) K183553

Compress and Mini Compress Anti-Rotation Spindles by Biomet, Inc. — Product Code MBF

K183553 is an FDA 510(k) premarket notification submitted by Biomet, Inc. for the device "Compress and Mini Compress Anti-Rotation Spindles". The FDA issued a decision of Substantially Equivalent on January 22, 2019. 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, Inc. has at least 10 other 510(k) clearances on record.