510(k) K973683 ยท MNH Orthosis, Spondylolisthesis Spinal Fixation
OMEGA 21 SYSTEM
| Applicant | Ebi Electro Biology, Parsippany NJ, US |
| Decision | Substantially Equivalent for Some Indications, Dec 24, 1997 |
| Received | Sep 26, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973683
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.