K250540
- 510(k) number
- K250540
- Device name
- SABER-C System
- Applicant
- Elevation Spine CA · US
- Product code
- OVE — Intervertebral Fusion Device With Integrated Fixatio
- Decision date
- 2025-08-08
- Date received
- 2025-02-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.4 MB · U.S. public domain
Also available from FDA: K250540.pdf
Official FDA record: K250540
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.