510(k) K243916 ยท NKB Thoracolumbosacral Pedicle Screw System
Primus Spinal Fixation System
| Applicant | Spinal Elements, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Feb 21, 2025 |
| Received | Dec 20, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243916
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.