510(k) K260037

implantcast Packaging System Update by Implantcast GmbH — Product Code LZO

K260037 is an FDA 510(k) premarket notification submitted by Implantcast GmbH for the device "implantcast Packaging System Update". The FDA issued a decision of Substantially Equivalent on March 30, 2026. 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.