510(k) K241269

mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis Kit by MED-EL Elektromedizinische Geräte GmbH — Product Code ETA

K241269 is an FDA 510(k) premarket notification submitted by MED-EL Elektromedizinische Geräte GmbH for the device "mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis Kit". The FDA issued a decision of Substantially Equivalent on January 17, 2025. The device falls under product code ETA (Replacement, Ossicular Prosthesis, Total), a Class II device regulated under 21 CFR 874.3495. MED-EL Elektromedizinische Geräte GmbH has at least 5 other 510(k) clearances on record.