510(k) K031083 ยท HTY Pin, Fixation, Smooth
OPUS MAGNUM IMPLANT SYSTEM, MODEL OM-1500
| Applicant | Opus Medical, Inc., San Juan Capistrano CA, US |
| Decision | Substantially Equivalent, Jun 12, 2003 |
| Received | Apr 4, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031083
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.