510(k) K182377 · NKB Thoracolumbosacral Pedicle Screw System
CarboClear® Pedicle Screw System
| Applicant | CarboFix Orthopedics , Ltd., Herzeliya, IL |
| Decision | Substantially Equivalent, Sep 27, 2018 |
| Received | Aug 31, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K182377
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.