510(k) K191632

PROFEMUR TL2 Stems by Microport Orthopedics, Inc. — Product Code LZO

K191632 is an FDA 510(k) premarket notification submitted by Microport Orthopedics, Inc. for the device "PROFEMUR TL2 Stems". The FDA issued a decision of Substantially Equivalent on October 7, 2019. 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. Microport Orthopedics, Inc. has at least 10 other 510(k) clearances on record.