K233989
- 510(k) number
- K233989
- Device name
- CarboClear® Posterior Cervical Screw System
- Applicant
- CarboFix Orthopedics , Ltd. IL
- Product code
- NKG — Posterior Cervical Screw System
- Decision date
- 2024-03-27
- Date received
- 2023-12-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K233989.pdf
Official FDA record: K233989
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.