510(k) K060518 ยท ETB Prosthesis, Partial Ossicular Replacement
PARTIAL OSSICULAR REPLACEMENT PROSTHESES
| Applicant | Grace Medical, Inc., Memphis TN, US |
| Decision | Substantially Equivalent, Jun 28, 2006 |
| Received | Feb 27, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060518
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 4, 2026 | Grace Medical, Inc. TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L
Model/Catalog Number: 409-375
Product Description: Stapes Prosthesis Open, Classified |
ETB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.