mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis Kit— 510(k) K241269
Substantially EquivalentMED-EL Elektromedizinische Geräte GmbH
FDA 510(k) clearance K241269 for mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis Kit, Substantially Equivalent on 2025-01-17. Applicant: MED-EL Elektromedizinische Geräte GmbH.
Clearance details
- Applicant
- MED-EL Elektromedizinische Geräte GmbH
- Product code
- Code ETA
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Innsbruck, AT
Data sourced from openFDA. This site is unofficial and independent of the FDA.