510(k) K031355 ยท NKB Thoracolumbosacral Pedicle Screw System
EBI SPINELINK - II SPINAL FIXATION SYSTEM
| Applicant | Ebi, L.P., Parsippany NJ, US |
| Decision | Substantially Equivalent, Jul 22, 2003 |
| Received | Apr 29, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031355
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.