510(k) K231655 · NKB Thoracolumbosacral Pedicle Screw System
4CIS® Chiron Spinal Fixation System
| Applicant | Solco Biomedical Co., Ltd., Pyeongtaek-Si, KR |
| Decision | Substantially Equivalent, Nov 26, 2024 |
| Received | Jun 6, 2023 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K231655
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.