510(k) K211548

POLARSTEM Calcar Reamer Guide by Smith & Nephew, Inc. — Product Code LZO

K211548 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Inc. for the device "POLARSTEM Calcar Reamer Guide". The FDA issued a decision of Substantially Equivalent on Jul 19, 2021. 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. Smith & Nephew, Inc. has 554 other 510(k) clearances on record.