510(k) K232586 · NKB Thoracolumbosacral Pedicle Screw System
Rexious Spinal Fixation System, Statera Spinal System, Statera-M Spinal System
| Applicant | K&J Consulting Corp., Lansdale PA, US |
| Decision | Substantially Equivalent, Oct 24, 2023 |
| Received | Aug 25, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K232586
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.