510(k) K191655 · NKB Thoracolumbosacral Pedicle Screw System
MEGAFIX® Pedicle Screw Spinal System
| Applicant | Seohancare Co., Ltd., Gimpo-Si, KR |
| Decision | Substantially Equivalent, Mar 6, 2020 |
| Received | Jun 21, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191655
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.