510(k) K183080 ยท NKB Thoracolumbosacral Pedicle Screw System
Mega Plus Spine System
| Applicant | Bk Meditech, Co., Ltd., Hwaseong-Si, KR |
| Decision | Substantially Equivalent, Dec 10, 2018 |
| Received | Nov 5, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K183080
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.