510(k) K200196

Taperloc® Complete Hip Stems by Biomet Orthopedics — Product Code LZO

K200196 is an FDA 510(k) premarket notification submitted by Biomet Orthopedics for the device "Taperloc® Complete Hip Stems". The FDA issued a decision of Substantially Equivalent on December 8, 2020. The device falls under product code LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented), a Class II device regulated under 21 CFR 888.3353. Biomet Orthopedics has at least 10 other 510(k) clearances on record.