K252153
- 510(k) number
- K252153
- Device name
- FFX Facet Fixation System
- Applicant
- Sc Medica FR
- Product code
- MRW — System, Facet Screw Spinal Device
- Decision date
- 2025-10-16
- Date received
- 2025-07-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K252153.pdf
Official FDA record: K252153
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.