K254061
- 510(k) number
- K254061
- Device name
- Curiteva Porous PEEK Cervical Interbody Fusion System
- Applicant
- Curiteva, Inc. AL · US
- Product code
- ODP — Intervertebral Fusion Device With Bone Graft, Cervic
- Decision date
- 2026-01-15
- Date received
- 2025-12-17
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K254061.pdf
Official FDA record: K254061
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.