510(k) K001357 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
MODIFICATION TO OMEGA 21 SYSTEM
| Applicant | Ebi, L.P., Parsippany NJ, US |
| Decision | Substantially Equivalent, Jul 20, 2000 |
| Received | Apr 28, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001357
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.