K241504
- 510(k) number
- K241504
- Device name
- iFuse TORQ TNT Implant System
- Applicant
- SI-BONE, Inc. CA · US
- Product code
- OUR — Sacroiliac Joint Fixation
- Decision date
- 2024-08-19
- Date received
- 2024-05-28
- 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: K241504.pdf
Official FDA record: K241504
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.