K232341
- 510(k) number
- K232341
- Device name
- CarboClear® Pedicle Screw System
- Applicant
- CarboFix Orthopedics , Ltd. IL
- Product code
- NKB — Thoracolumbosacral Pedicle Screw System
- Decision date
- 2023-10-10
- Date received
- 2023-08-04
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K232341.pdf
Official FDA record: K232341
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.