510(k) K231737 · NKB Thoracolumbosacral Pedicle Screw System
ANAX 5.5 Spinal System
| Applicant | Innosys Co., Ltd., Uijeongbu-Si, KR |
| Decision | Substantially Equivalent, Oct 26, 2023 |
| Received | Jun 14, 2023 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K231737
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.