K233944
- 510(k) number
- K233944
- Device name
- CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments
- Applicant
- CarboFix Orthopedics , Ltd. IL
- Product code
- NKB — Thoracolumbosacral Pedicle Screw System
- Decision date
- 2024-01-10
- Date received
- 2023-12-14
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.4 MB · U.S. public domain
Also available from FDA: K233944.pdf
Official FDA record: K233944
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.