K250637
- 510(k) number
- K250637
- Device name
- VCFix Spinal System
- Applicant
- Amber Implants NL
- Product code
- NDN — Cement, Bone, Vertebroplasty
- Decision date
- 2025-05-30
- Date received
- 2025-03-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K250637.pdf
Official FDA record: K250637
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.