510(k) K232371

Actinia® hip stems by Implantcast GmbH — Product Code LZO

K232371 is an FDA 510(k) premarket notification submitted by Implantcast GmbH for the device "Actinia® hip stems". The FDA issued a decision of Substantially Equivalent on October 19, 2023. 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.