K240699
- 510(k) number
- K240699
- Device name
- SCARLET® AC-Ti
- Applicant
- Spineart SA CH
- Product code
- OVE — Intervertebral Fusion Device With Integrated Fixatio
- Decision date
- 2024-05-10
- Date received
- 2024-03-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K240699.pdf
Official FDA record: K240699
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.