510(k) K190526 · PML Bone Cement, Posterior Screw Augmentation
High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws
| Applicant | CarboFix Orthopedics , Ltd., Herzeliya, IL |
| Decision | Substantially Equivalent, Sep 19, 2019 |
| Received | Mar 4, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190526
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.