510(k) K172267 ยท NKB Thoracolumbosacral Pedicle Screw System
IRENE Thoracolumbar Fixation System
| Applicant | Tianjin Zhengtian Medical Instrument Co., Ltd., Tianjin, CN |
| Decision | Substantially Equivalent, Mar 6, 2018 |
| Received | Jul 27, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172267
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.