510(k) K240391

MUTARS® femoral stem cemented 160 mm and 200 mm by Implantcast GmbH — Product Code LZO

K240391 is an FDA 510(k) premarket notification submitted by Implantcast GmbH for the device "MUTARS® femoral stem cemented 160 mm and 200 mm". The FDA issued a decision of Substantially Equivalent on October 24, 2024. 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. Implantcast GmbH has at least 10 other 510(k) clearances on record.