510(k) K200007

PROFEMUR GLADIATOR Thin HA Classic Hip Stem with Collar by Microport Orthopedics, Inc. — Product Code LZO

K200007 is an FDA 510(k) premarket notification submitted by Microport Orthopedics, Inc. for the device "PROFEMUR GLADIATOR Thin HA Classic Hip Stem with Collar". The FDA issued a decision of Substantially Equivalent on April 25, 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. Microport Orthopedics, Inc. has at least 10 other 510(k) clearances on record.