510(k) K243004 ยท NKB Thoracolumbosacral Pedicle Screw System
Xpine Spinal Fixation System
| Applicant | Jeil Medical Corporation, Seoul, KR |
| Decision | Substantially Equivalent, Nov 8, 2024 |
| Received | Sep 26, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243004
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.