K240086
- 510(k) number
- K240086
- Device name
- Ion 3D
- Applicant
- SurGenTec, LLC FL · US
- Product code
- MRW — System, Facet Screw Spinal Device
- Decision date
- 2024-02-08
- Date received
- 2024-01-11
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K240086.pdf
Official FDA record: K240086
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.