510(k) K031354 ยท MNI Orthosis, Spinal Pedicle Fixation
EBI OMEGA21 SPINAL FIXATION SYSTEM
| Applicant | Ebi, L.P., Parsippany NJ, US |
| Decision | Substantially Equivalent, Aug 6, 2003 |
| Received | Apr 29, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031354
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.