K253260
- 510(k) number
- K253260
- Device name
- ORIO-3D Cage System
- Applicant
- SpineCraft IL · US
- Product code
- ODP — Intervertebral Fusion Device With Bone Graft, Cervic
- Decision date
- 2026-04-16
- Date received
- 2025-09-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K253260.pdf
Official FDA record: K253260
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.