510(k) K231280 · NKB Thoracolumbosacral Pedicle Screw System
CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X Fenestrated Pedicle Screw System with High V+® Bone Cement
| Applicant | CarboFix Orthopedics , Ltd., Herzeliya, IL |
| Decision | Substantially Equivalent, Jul 3, 2023 |
| Received | May 3, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231280
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.