510(k) K181139 ยท NKB Thoracolumbosacral Pedicle Screw System
OLYMPIC Posterior Spinal Fixation System
| Applicant | Astura Medical, LLC, Carlsbad CA, US |
| Decision | Substantially Equivalent, Jul 6, 2018 |
| Received | Apr 30, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181139
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.