510(k) K241142 · ETB Prosthesis, Partial Ossicular Replacement
mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis
| Applicant | MED-EL Elektromedizinische Geräte GmbH, Innsbruck, AT |
| Decision | Substantially Equivalent, Jan 17, 2025 |
| Received | Apr 25, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K241142
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.