510(k) K014137 ยท MNH Orthosis, Spondylolisthesis Spinal Fixation
MODIFICATION TO EBI OMEGA 21 SYSTEM
| Applicant | Ebi, L.P., Parsippany NJ, US |
| Decision | Substantially Equivalent, Jan 16, 2002 |
| Received | Dec 17, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K014137
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.