510(k) K081747 ยท NEI Prosthesis, Condyle, Mandibular, Temporary
MODIFICATION TO SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM
| Applicant | Synthes (Usa), West Chester PA, US |
| Decision | Substantially Equivalent, Sep 5, 2008 |
| Received | Jun 19, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081747
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.