510(k) K240846 · NKB Thoracolumbosacral Pedicle Screw System
CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments; CarboClear® Hybrid Fenestrated Pedicle Screw System and High V+® Bone Cement; CarboClear® X Fenestrated Pedicle Screw System and High V+® Bone Cement
| Applicant | CarboFix Orthopedics , Ltd., Herzeliya, IL |
| Decision | Substantially Equivalent, Apr 25, 2024 |
| Received | Mar 27, 2024 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K240846
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.