K251714
- 510(k) number
- K251714
- Device name
- Ion-C
- Applicant
- SurGenTec, LLC FL · US
- Product code
- MRW — System, Facet Screw Spinal Device
- Decision date
- 2026-01-16
- Date received
- 2025-06-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K251714.pdf
Official FDA record: K251714
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.