K254045
- 510(k) number
- K254045
- Device name
- CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System
- Applicant
- CarboFix Orthopedics , Ltd. IL
- Product code
- NKG — Posterior Cervical Screw System
- Decision date
- 2026-03-16
- Date received
- 2025-12-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K254045.pdf
Official FDA record: K254045
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.