K261209
- 510(k) number
- K261209
- Device name
- Ion-L
- Applicant
- SurGenTec, LLC FL · US
- Product code
- MRW — System, Facet Screw Spinal Device
- Decision date
- 2026-06-11
- Date received
- 2026-04-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K261209.pdf
Official FDA record: K261209
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.