510(k) K231443 · NKB Thoracolumbosacral Pedicle Screw System
Mini-OSTEO Pedicle Fixation System
| Applicant | Osteomed Indústria E Comércio DE Implantes Ltda, Rio Claro, BR |
| Decision | Substantially Equivalent, Nov 21, 2023 |
| Received | May 18, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231443
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.