510(k) K254045 · NKG Posterior Cervical Screw System
CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System
| Applicant | CarboFix Orthopedics , Ltd., Herzeliya, IL |
| Decision | Substantially Equivalent, Mar 16, 2026 |
| Received | Dec 17, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K254045
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.