K250845
- 510(k) number
- K250845
- Device name
- Curiteva Porous PEEK Standalone ALIF System
- Applicant
- Curiteva, Inc. AL · US
- Product code
- OVD — Intervertebral Fusion Device With Integrated Fixatio
- Decision date
- 2025-06-18
- Date received
- 2025-03-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K250845.pdf
Official FDA record: K250845
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.