510(k) K061749 ยท HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
ECLIPSE TOTAL ANKLE IMPLANT
| Applicant | Kinetikos Medical, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Nov 22, 2006 |
| Received | Jun 21, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061749
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.