K241142
- 510(k) number
- K241142
- Device name
- mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis
- Applicant
- MED-EL Elektromedizinische Geräte GmbH AT
- Product code
- ETB — Prosthesis, Partial Ossicular Replacement
- Decision date
- 2025-01-17
- Date received
- 2024-04-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ear, Nose, Throat
PDFDownload 510(k) SummaryArchived here · 2.1 MB · U.S. public domain
Also available from FDA: K241142.pdf
Official FDA record: K241142
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.