510(k) K260718 · ETB Prosthesis, Partial Ossicular Replacement
mGRIP Partial Prosthesis (0.75 mm) (58669);mGRIP Partial Prosthesis (1.00 mm) (58671);mGRIP Partial Prosthesis (1.25 mm) (58673);mGRIP Partial Prosthesis (1.50 mm) (58675);mGRIP Partial Prosthesis (1.75 mm) (58677);mGRIP Partial Prosthesis (2.00 mm) (58679);mGRIP Partial Prosthesis (2.25 mm) (58681)
| Applicant | MED-EL Elektromedizinische Geräte GmbH, Innsbruck, AT |
| Decision | Substantially Equivalent, Apr 3, 2026 |
| Received | Mar 5, 2026 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K260718
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.