510(k) K032394 ยท MNI Orthosis, Spinal Pedicle Fixation
STRYKER SPINE OASYS SYSTEM
| Applicant | Howmedica Osteonics Corp., Allendale NJ, US |
| Decision | Substantially Equivalent, Feb 20, 2004 |
| Received | Aug 4, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K032394
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.