510(k) K002897 ยท ETB Prosthesis, Partial Ossicular Replacement
TITANIUM MIDDLE EAR PROSTHESES
| Applicant | Xomed, Inc., Jacksonville FL, US |
| Decision | Substantially Equivalent, Oct 11, 2000 |
| Received | Sep 18, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002897
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 26, 2013 | Medtronic Xomed, Inc. Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The ear prosthesis is implantable and indicated for hearing loss. Terminated |
ETA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.