K253488
- 510(k) number
- K253488
- Device name
- iFuse INTRA Ti Implant System
- Applicant
- SI-BONE, Inc. CA · US
- Product code
- OUR — Sacroiliac Joint Fixation
- Decision date
- 2026-02-11
- Date received
- 2025-10-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K253488.pdf
Official FDA record: K253488
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.